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Assure Labs Inc.

5250 Gulfton St #2C, 77081 Houston, TX
USA
Telephone +1 713 5615529
Fax +1 713 8568399
sales@assurelabs.com

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Contact

Veronica Yu

Sales manager-America region

Phone
86 137 3229 7552
whatsapp:86 13732297552

Email
veronica.yu@diareagent.com

Andrea Xu

Sales manager -Latin America/South America/Central America

Phone
+86 188 5861 9815
whatsapp:86 188 5861 9815

Email
andrea.xu@diareagent.com

Maggie Liu

Sales manager-North American

Phone
+86-13957703675
whatsapp:86-13957703675

Email
maggie.liu@diareagent.com

Diego Yang

Sales manager-south america/mexico

Phone
+86 13285851276
WhatsAPP/Wechat: +86 13285851276

Email
diego.yang@diareagent.com

Frank Luo

Sales manager-America

Our products

Product category: Diagnostic rapid tests

POC AUTHORIZED! COVID-19 IgG/IgM Rapid Test Device

The COVID-19 IgG/IgM Rapid Test Kit is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum or plasma. The test is for professional use only.

Benefits:
Results in 15 minutes
High accurate
Easy to use
No equipment required

Features:
Packing Size:20 pcs/kit
Sample:Whole blood/Serum/Plasma
Sample Volume:5ul
Testing time:15min
Shelf life:24 mouths
Storeage condition:4-30℃

Packing Contents:
Tests
disposable pipettes
Buffer
Package insert

Performance:
For IgM detection
Relative sensitivity: 93.7% (86.0%-97.3%)*
Relative specificity: 99.1% (96.8%-99.8%)*
Overall agreement: 97.7% (95.4%-98.9%)*
*95% Confidence Interval

For IgG detection:
Relative sensitivity: 98.8% (93.5%-99.8%)*
Relative specificity: 98.7% (96.2%-99.5%)*
Overall agreement: 98.7% (96.7%-99.5%)*
*95% Confidence Interval

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Product category: Diagnostic rapid tests

COVID-19 Antigen Rapid Test Device

The COVID-19 Antigen Rapid Test Device is an in vitro immunoassay. The assay is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from nasopharyngeal secretions and Oropharyngeal secretions. This test is intended for professional use only.

Benefits:
Directly detect SARS-CoV-2 virus
Easy to use
No equipment required
Rapid detection within 15 minutes

Features:
Packing Size:20 pcs/kit
Sample:Nasopharyngeal/Oropharyngeal Swab
Testing time:15min
Storeage condition:2-30℃

Performance:
Relative Sensitivity: 94.3 % (84.6% ~ 98.1%)*
Relative Specificity: 99.1 % (98.4% ~ 99.5%)*
Overall Agreement: 98.9 % (98.1% ~ 99.4%)*
*95% Confidence Interval

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Product category: Diagnostic rapid tests

COVID-19 Antigen & Influzen A/B Combo Rapid Test Device

The COVID-19 & Influenza A/B Antigen Combo Test Device is an in vitro immunoassay. The assay is for the direct and qualitative detection of Influenza A and B and SARS-CoV-2 viral nucleoprotein antigens from nasopharyngeal secretions. This test is intended for professional use only.

Benefits:
Detection and differentiation of flu, COVID-19 during respiratory season
Results in 15 minutes
High accurate
Easy to use

Features:
Packing Size:25 pcs/kit
Sample:Nasopharyngeal Swab
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃

Performance:
For COVID-19 antigen :
Relative Sensitivity: 97.3 % (86.2%~99.5%) *
Relative Specificity: 100 % (89.0%~100%)*
Overall Agreement: 98.5 % (92.1%~99.7 %)*
*95% Confidence Interval

For Influenza A:
Positive agreement with Cell Culture: 83.3%(73.5%~90.0%) *
Negative agreement with Cell Culture: 92.0%(85.4%~95.7%) *
Total agreement with Cell Culture: 88.4%(83.1%~92.2%) *
*95% Confidence Interval

For Influenza B:
Positive agreement with Cell Culture: 82.4%(72.9%~89.0%) *
Negative agreement with Cell Culture: 94.3%(88.1%~97.4%) *
Total agreement with Cell Culture: 88.9%(83.7%~92.7%) *
*95% Confidence Interval

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Product category: Diagnostic rapid tests

COVID-19-FLUA-FLUB-RSV-ADV-Combo Test Device

The FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device is an in vitro immunoassay. The assay is for the direct and qualitative detection of influenza A virus, influenza B virus, Respiratory Syncytial Virus (RSV), Adenovirus (ADV) and SARS-CoV-2 antigens from nasopharyngeal swab samples.

Benefits:
•Quick results in 15 minutes
•Detection and differentiation of flu, RSV, ADV and COVID-19 during respiratory season
•Identify the co-infections of flu,RSV,ADV and COVID-19
•Provide judgment on health care workers for the similar symptoms disease

Specification:
Specimen: Nasal Secretions
Storage:2-30℃,room temperature
Shelf life:24 mouths
Kit package:20pcs
Testing time:15 minutes

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Product category: Diagnostic rapid tests

MDSAP! Influenza A/B Rapid Test Device

The Influenza A/B Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal/nasopharyngeal swabs and nasal washes/aspirates of humans. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. The test is not intended for the detection of influenza C viral antigens. Negative results do not preclude influenza A or B viral infections and should be confirmed via cell culture or molecular assay

Benefits:
Results in 15 minutes
High accurate
Easy to use

Features:
Packing Size:25 pcs/kit
Sample:Nasal/NP Swab and Nasal Washes/Aspirate
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃

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Product category: Diagnostic rapid tests

MDSAP certificate! H. pylori Antibodies Rapid Test Device

The H. pylori Antibody Rapid Test Device (Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of specific IgG antibodies to Helicobacter pylori in human serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of H. pylori infection.

Benefits:
Results in 10 minutes
High accuracy
Easy to use
No equipment required

Features:
Packing Size:40 pcs/kit
Sample:Urine
Testing time:10min
Shelf life:24 mouths
Storeage condition:2-30℃

Performance:
Relative Sensitivity:>93.2% (89.5%-95.9%)*
Relative Specificity:>97.2% (94.9%-98.6%)*
Overall Agreement:>95.5% (93.5%-97.0%)*
*95% Confidence Interva

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Product category: Diagnostic rapid tests

Handheld Drug of Abuse Reader

A maximum of 9 drugs can be tested at a time, with more than 40 tests covering all common drugs

Benefits:
Portable &rear camera
User-friendly interface
4.3’’ touch screen
Inner Thermal printer
Stores up to 5000 results
Precise & accurate results in 5-10 minutes
External power and built-in rechargeable battery
Data can be transferred via cloud,Wi-Fi,support GPS ,GLONASS ,Beidou ,Bluetooth, TF card

Application: Hospital, Laboratory, Medical center , On-site enforcement

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Product category: Diagnostic rapid tests

FDA 510k! Turn-Key Split Cup MD-U621 Drugs of Abuse Integrated Cup

The Turn-Key Split Cup Drugs of Abuse Integrated Cup(Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of any combination of drugs of abuse in human urine specimens at the cut-off concentrations listed below:
ACE Acetaminophen 5000ng/mL
AMP d-Amphetamine 1000/500/300ng/mL
BAR Secobarbital 300ng/mL
BUP BUP-3-D-Glucuronide 10/5ng/mL
BZO Oxazepam 300/200/100ng/mL
COC Benzoylecgonine 300/150/100ng/mL
COT (-)-Cotinine 600/300/200ng/mL
EDDP 2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine 300/100ng/mL
ETG Ethyl Glucuronide 500ng/mL
FYL Norfentanyl/Fentanyl 200/10ng/mL
HMO Hydromorphone 250ng/mL
K2 JWH-073/JWH-018 50ng/mL
KET Ketamine 1,000ng/mL
LSD 9,10-Didehydro-N,N-diethyl-6-methylergoline-8beta-carboxamide 50ng/mL
6-MAM 6-Monoacetylmorphine 10ng/mL
MDMA 3,4-Methylenediioxy-MET 1000/300ng/mL
MET Methamphetamine 1000/500/300ng/mL
MOP Morphine 300/200/100ng/mL
MPD Methylphenidate 300ng/mL
MQL Methaqualone 300ng/mL
MTD Methadone 300ng/mL
OPI Morphine 2000/1000ng/mL
OXY Oxycodone 300/100ng/mL
PCP Phencyclidine 25ng/mL
PPX D-Propoxyphene 300ng/mL
TCA Nortriptyline 1000ng/mL
THC 11-nor-△9-THC-9-COOH 200/150/50/25
TRA Tramadol 300/100ng/mL
ZOL Zolpidem 50ng/mL
ALC Alcohol 0.02%
Adulteration
( StripA) Oxidants/ Specific Gravity / pH
Adulteration
( StripB) Nitrite / Glutaraldehyde/Creatinine

Benefits:
Results in 15 minutes
High accurate
Easy to use

Features:
Packing Size:25 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃

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Product category: Diagnostic rapid tests

FDA 510k! Dipstick Drug Screen Panels (Urine)

The DOA Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to seven of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:
AMP d-Amphetamine 1000 ng/ml
BAR Secobarbital 300 ng/ml
BZO Oxazepam 300 ng/ml
COC Benzoylecgonine 300 ng/ml
MOR Morphine 300 ng/ml
THC 11-nor-D9-THC-9-COOH 50 ng/ml
TML Tramadol 100 ng/ml

Benefits:
Results in 5 minutes
High accurate
Easy to use

Features:
Packing Size:25 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃

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Product category: Diagnostic rapid tests

Multi DOA Saliva Test Cup

The Rapid Response TMMulti DOA Saliva Test Cup is a rapid visual immunoassay for the qualitative detection of drugs of abuse in human oral fluid specimens. The test system consists of up to 16 membrane strips mounted in a plastic device. This test detects combinations of the following drugs at the concentrations listed below. Specific combinations will vary according to the test in question:
Amphetamine (AMP) 50ng/ml
Barbiturate(BAR) 50ng/ml
Benzodiazepine (BZO) 10ng/ml
Buprenorphine(BUP) 5ng/ml
Cocaine (COC) Cocaine 20ng/ml
Cotinine(COT) Cotinine 50ng/ml
EDDP(EDDP) 20ng/ml
K2 50ng/ml
Ketamine (KET) 50ng/ml
Methadone (MTD) 30ng/ml
Methamphetamine (MET) 50ng/ml
Ecstasy (MDMA) 50ng/ml
6-MAM 10ng/ml
Opiates (OPI) 40ng/ml
Opiates (OPI) 25ng/ml
Oxycodone(OXY) 20ng/ml
Phencyclidine (PCP) 10ng/ml
Propoxyphene(PPX) 50ng/ml
Marijuana (THC) 12ng/ml
Marijuana (THC parent) 40ng/ml
Alcohol(ALC) 0.02%

Benefits:
Results in 10 minutes
High accurate
Easy to use

Features:
Packing Size:25 pcs/kit
Sample:Urine
Testing time:10min
Shelf life:24 mouths
Storeage condition:2-30℃

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Product category: Diagnostic rapid tests

FDA 510k! Marijuana THC Rapid Test Device

The THC Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative presumptive detection of THC metabolites (11-nor-Δ9-THC-9-carboxylic acid) in human urine specimens.

Marijuana, cannabis or tetra-hydro-cannabinol (THC) is a hallucinogenic agent derived from the flowering portion of the hemp plant. Smoking is the primary method of use of marijuana/cannabis.Higher doses used by abusers produce central nervous system effects, altered mood and sensory
perceptions, loss of co-ordination, impaired short-term memory, anxiety, paranoia, depression,confusion,hallucinations and increased heart rate.

Benefits:
Results in 5 minutes
High accurate
Easy to use

Features:
Packing Size:40 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃

Performance:
The results were >99.9% in agreement

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Product category: Diagnostic rapid tests

FDA 510k! Amphetamine9(AMP) Rapid Test 300 /500/ 1000ng/ml

The AMP Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Amphetamine in human urine specimens

Amphetamine is a Schedule II controlled substance available by prescription (Dexedrine®) and is also available on the illicit market. Amphetamines are a class of potent sympathomimetic agents with therapeutic applications. They are chemically related to the human body’s natural catecholamines: epinephrine and norepinephrine. Acute higher doses lead to enhanced stimulation of the central nervous system and induce euphoria, alertness, reduced appetite, and a sense of increased energy and power.

Benefits:
Results in 5 minutes
High accurate
Easy to use

Features:
Packing Size:40 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃

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Product category: Diagnostic rapid tests

RSV Antigen Rapid Test Device (Nasal Secretions)

The RSV Antigen Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of respiratory syncytial virus (RSV) antigens from human nasal/nasopharyngeal swabs or nasal washes/aspirates. It is intended to aid in the rapid diagnosis of RSV infection. Negative results do not preclude RSV infection and should be confirmed via bacterial culture or molecular assay.

Benefits:
Results in 15 minutes
Over 98% Accuracy
Easy to use
Digital test

Features:
Packing Size:1pcs/kit
Sample:Nasal Secretions
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃

PERFORMANCE:
Relative sensitivity: 97.9% (95.2%-99.1%)*
Relative specificity: 99.3% (98.1%-99.8%)*
Overall agreement: 98.8% (97.7%-99.4%)*
*95% Confidence Interval

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Product category: Diagnostic rapid tests

Fluorescence Immunoassay Analyzer

The fluorescence immunoassay analyzer is compatible with a specific dry reagent based on fluorescence immune chromatography, which is used for immune fluorescence detection in human specimens. It can be applied to the central laboratory of medical institution, door/emergency laboratory, clinical department and other medical service points (such as community medical center), physical examination center, etc., also applicable to research laboratory.

Benefits:
Portable analyzer
Accurate results
Quantitative test

Features:
internal and external controls
Built-in thermal printer
More than 9900 results
LIS/HIS connection
USB port/ID card/ Ethernet
RS-232 port/LAN port/WIFI
333*251*157mm 2.5Kg
12V DV max 4A / 100-240V AC,50-60HZ

Test Items:
Cardiac Markers:TRO,DDM,CK-MB,NT-proBNP,MYO,cTnI,LP-PLA2
Inflammation Marks:CRP,SAA,PCT,IL-6,sST2,CRP&SAA
Fertility Test:β-HCG,LH,FSH,Prog,PRL,E2,T
Tumor Marks:AFP,CEA,FRT,PSA,FOB
Renal Injury Markers:NGAL,Cys-C,β2-MG,MAU
Gastric function Marks:PGⅠ,PGⅡ
Thyroid Function:T3,TT4,TSH
Diabetic:HbA1c
others:Vd3,COR

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Product category: Diagnostic rapid tests

Pregnancy (HCG) Rapid Test

The hCG Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine specimens. This kit is intended for using as an aid in the early detection of pregnancy.

Benefits:
Over 99% accuracy
Results in 3 minutes
Easy to use
No equipment required

Features:
Packing Size:40 pcs/kit
Sample:Urine
Testing time:3min
Shelf life:24 mouths
Storeage condition:2-30℃

Performance:
Relative Sensitivity:>99.9% (98.7%-99.9%)*
Relative Specificity:>99.9% (99.8%-100.0%)*
Overall Agreement:>99.9% (99.7%-99.9%)*
*95% Confidence Interval

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Product category: Diagnostic rapid tests

Ovulation(LH)Rapid Test Device

The LH Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of luteinizing hormone in human urine specimens. This kit is intended for use as an aid in the detection of ovulation.

Benefits:
Results in 5 minutes
High accurate
Easy to use

Features:
Packing Size:25 pcs/kit
Sample:Urine
Testing time:5min
Shelf life:24 mouths
Storeage condition:2-30℃

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Product category: Diagnostic rapid tests

Blood Glucose Monitoring System

Blood Glucose Monitoring System is designed to quantitatively measureglucose with fresh capillary whole blood or venous whole blood. The system is intended for use outside the human body as an aid to monitor the effectiveness of diabetes control. The Blood Glucose Monitoring System is not used for the diagnosis of the diabetes or test of newborns.

Benefits:
Low pain
Accurate result in just 5 seconds
Only a drop of blood required
Stores up to 200 results with date and time
Wide temperature humidity

Specifications
Feature Specification
Measurement range :20~600mg/dL(1.1-33.3mmol/L)
Sample:Fresh capillary or venous whole blood
Sample size:Approximate 1 microlitre
Measuring time:5 seconds
Meter size:84.7*52*18mm (L*W*H)
Battery life:6 months or approximately 1,000 tests

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Product category: Diagnostic rapid tests

Hemoglobin Monitoring System

The Hemoglobin Meter is intended for the quantitative determination of Hemoglobin (Hb) and calculated Hematocrit (HCT) in capillary and venous human whole blood. The easy to operate system consists of a portable meter that analyzes the intensity and color of light reflected from the reagent area of a test strip, ensuring quick and accurate results.

Benefits
Testing time less than 15 seconds
Capillary and venous human whole blood
A single drop(10ul) of whole blood
High memory of 500 records

Specifications
Test Time:<15 seconds
Measurement Range:0-25.6 g/dL, 0-256 g/L or 0-15.9 mmol/L
Sample:Whole blood
Sample Volume:10 μL
Battery Life:100 hours or 1,000 tests
Memory:1,000 records
Meter Size:142 mm × 70 mm × 27 mm

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Product category: Diagnostic rapid tests

Cholesterol monitoring system

The Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol (TC), High Density Lipoprotein Cholesterol(HDL), Triglycerides (TG), and the calculated ratio of TC/HDL and Low Density Lipoprotein Cholesterol (LDL) in human capillary blood. The easy to operate system consists of a portable meter that analyzes the intensity and color of light reflected from the reagent area of a test device, ensuring quick and accurate results.

Benefits:
Easy to use
Getting result in just 120 seconds
Large memory
Stores up to 500 results
Rapid detection
One test can get five results
Power saving mode

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Product category: Diagnostic rapid tests

ZIKA IgG/IgM Rapid Test Device

The ZIKA IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is an in vitro immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to Zika virus in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of Zika infections. The results obtained should be confirmed with alternative testing method(s).

Benefits:
Results in 15 minutes
High accurate
Easy to use

Features:
Packing Size:25 pcs/kit
Sample:Whole Blood/Serum/Plasma
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃

Performance:
The overall agreement for IgG test is 90%; the overall agreement for IgM test is 90%.

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Product category: Diagnostic rapid tests

MDSAP certificate! Malaria P.f/Pan Rapid Test Device

The Malaria P.f/Pan Rapid Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood.

Benefits:
Results in 15 minutes
High accurate
Easy to use

Features:
Packing Size:25 pcs/kit
Sample:Whole Blood
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃

Performance:
Relative Specificity: 99.1% (324/327)(97.3%~99.8%)*
Accuracy: 99.4% (535/538)(98.3%~99.8%)*
For Pan:
Relative Sensitivity: >99.9% (158/158) (97.6%~100.0%)*
For P.f:
Relative Sensitivity: >99.9% (53/53) (93%~100.0%)*
*95% Confidence Interval

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Product category: Diagnostic rapid tests

Dengue IgG/IgM Rapid Test Device

The Dengue IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Denguevirus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections.

Benefits:
Results in 15 minutes
High accurate
Easy to use

Features:
Packing Size:25 pcs/kit
Sample:Whole Blood/Serum/Plasma
Testing time:15min
Shelf life:24 mouths
Storeage condition:2-30℃

Performance:
For Dengue IgM test:
Relative sensitivity:98.3%(91.1%~99.7%)*
Relativespecificity: >99.9%(97.3%~100.0%)*
Overall agreement: 99.5%(97.2%~99.9%)*
*95% Confidence Interval
For Dengue IgG test:
Relative sensitivity:
98.9%(94.0%~99.8%)*
Relative specificity:
>99.9%(97.5%~100.0%)*
Overall agreement:
99.6%(97.7%~99.9%)*
*95% Confidence Interval

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About us

Company details

Azure Biotech, Inc.is a high-tech biotechnology company that specializes in research & development, production and sales of diagnostic reagents, POCT analyzers, and biological materials. We utilize advanced colloidal gold diagnostic reagents production lines to produce hundreds of millions of devices each year. Currently, our R&D team has over 100 employees, along with extensive collaborations with renowned domestic and foreign research institutions.

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