iso 13485 poct test kit

Brand Name:WWHS

Place of Origin:CN

Model Number:S100-β

【Product Name】 Diagnostic Kit for S100β protein(Immunochromatographic assay) 【Packing Specification】 25 Tests/kit 【Intended Use】 The kit is used for quantitative determination of S100β in human whole blood, serum or plasma. Clinically, by detecting the ...

Brand Name:INVBIO

Model Number:INV-281

Place of Origin:China

ISO Medical Diagnostic Human Papilloma Virus (HPV) Antigen Rapid Test Kit The Syphilis Test Card is a diagnostic tool used to detect the presence of antibodies against Treponema pallidum in a patient's blood. The test is simple, quick, and can be performed in a doctor's office or clinic. The test card works by detecting the presence of antibodies against Treponema pallidum in the patient's blood. The test...

Brand Name:Miss Lan

Model Number:DC081A

Place of Origin:Guangzhou, China

510k/CE/ISO Quality Assurance Digital Pregnancy Easy Test Midstream Intended use The MissLan Digital hCG Pregnancy Test is for early detection of pregnancy. It's a one-step rapid test to give you a result of "+/pregnant" or "-/not pregnant" in 5 minutes...

Brand Name:MAITE

Model Number:Breast Milk Alcohol Test Strips

Place of Origin:Jilin, China

Breastmilk Alcohol Test Strips Mother'S Breast Milk Testing With Fast And Reliable Analysis Intended use for Alcohol Test: One Step Alcohol breast milk Test is intended for use as a rapid method to detect the presence of alcohol in breast milk for blood ...

Brand Name:iiLO

Model Number:Antigen Test Set

Place of Origin:Suzhou China

...Test Kit Self Test Class III Certification CE2934 ISO:13485 iiLO Antigen Swab Test Kits SARS-CoV-2 Testing European self-test versions Class III 1 Test/Box The antigen detection test of NewGene makes use of saliva as the sample and is therefore a non-invasive rapid test. The COVID-19 Antigen Detection Kit...

Brand Name:iiLO

Model Number:Antigen Test Set

Place of Origin:Suzhou China

...Test Kit Self Test Class III Certification CE2934 ISO:13485 iiLO Antigen Swab Test Kits SARS-CoV-2 Testing European self-test versions Class III 1 Test/Box The antigen detection test of NewGene makes use of saliva as the sample and is therefore a non-invasive rapid test. The COVID-19 Antigen Detection Kit...

Brand Name:Getein

Model Number:JR-TK01

Place of Origin:CHINA

...test kit quantitative test for diagnostic POCT analyzer Getein 1100 1. Getein IL-6 test card in a sealed pouch with desiccant 2. Disposable pipet 3. User manual: 1 piece/box 4. SD/RFID card: 1 piece/box 5. Whole blood buffer: 1 bottle/box Product Name IL-6 Fast Test Kit (Immunofluorescence Assay) Test Time 15 Min Storage Condition 4-30℃(test cards) Shielf Life 24 months Test Item IL-6 Kit size 25 Tests/Kit...

Brand Name:Newscen

Model Number:COVID-19 IgG/IgM

Place of Origin:China

... Design ☀ High Accurate (97.51%) and Reliable ☀ Ambient storage. ☀ Meet Multiple Criteria as follows: EN ISO 13485:2016 EN 13612:2002 EN ISO 14971:2012 EN ISO 23640:2015 EN ISO 18113-1:2011 EN ISO 18113-2:2011 EN ISO 15223-1

Brand Name:LABNOVATION

Place of Origin:Shenzhen, China

POCT For HbA1c Analyzer Ues Various Hemtology Analyzer testing Kit Hemoglobin A1c Test Kits Intended Use The Hemoglobin A1c Test Kits (Boronate Affinity) (herein after referred to as kits) adopt the principle of boronate affinity to use with the LD-100 POCT...

Brand Name:Ascentet

Model Number:Covid Test Kit

Place of Origin:China

...POCT Covid-19 2019-NCoV Antigen Rapid Test Kit Product Parameters: Product Name Novel SARS-Cov-2 Antigen Rapid Test Cassette (Swab) Specifications 1/5/25 Test(s)/Kit Certificates CE, ISO,,ARTG, DIMDI Storage 2~30℃ Specimen Type Nasopharyngeal Swab Shelf Life 24 months Use For Professional use only Features High sensitivity and Specificity Main Components Name Item Spec. PCR amplification kit...

Brand Name:OEM

Model Number:CT-C02

Place of Origin:CHINA

THC / AMP / MOP / COC up to 16 items ( Max ) for Drug Test Strip / Dipcard / Cassette / Cup 1. Accuracy:Over 99%. 2. Time to results: within 5 minutes comes out. 3. Specimen: Urine. 4. Storage: 4°C - 30°C. 5. Shelf Life: 24 months. Single Panel Drug Test ...

Brand Name:Biokey

Model Number:BIK-QL-H006 / BIK-QL-H006S

Place of Origin:Guangzhou China

Clostridium difficile ( CD ) associated infection PCR Fluorescent probing Taqman test kit Intended use: This kit, adopting Real-Time PCR-Fluorescence technology, is used for qualitative detection of Clostridium difficile. It can be used for the laboratory ...

Brand Name:sinocare

Model Number:Gold-Accu Glucose Meter mg/GL

Place of Origin:China

... based on biosensor, combining the rapid development of information technology and networking technology with POCT products, continue to provide tools of detection for patients, also provide the data analysis and expert services, to realize the

Brand Name:Singuway

Model Number:FastPCR001

Place of Origin:China

High Precision RT PCR Test Kit POCT IVD Clinical Diagnosis For hepatitis B C virus Product Introduction: Singuway Real Time PCR Detection Kit is developed by our RD independently.Easy to operate and high efficiency. Features: High sample coverage rate & ...

Brand Name:OEM

Model Number:Nucleic Acid Test Kit

Place of Origin:CHINA

High Sensitive Diagnostic Test Kit POCT Procalcitonin (PCT) Rapid Test APPLICATION Screening in primary medical facilities, on patients and on healthcare staff Screening on commuter population Suspicious cases in epidemic areas, for example in case of ...

Brand Name:Aichek

Model Number:COVID-19-G02001A

Place of Origin:China

Easy to operate for SARS-CoV-2 IgG IgM Antibody Rapid Test Kit For professional and in vitro diagnostic use only. Product Name Easy to operate for SARS-CoV-2 IgG IgM Antibody Rapid Test Kit Formats Strip(3mm)Device(4mm) uncut sheet Place of Origen China ...

Brand Name:Ascentet

Model Number:OEM

Place of Origin:China

... swab samples in vitro.. This kit is offered to clinical laboratories and healthcare workers for point-of-care testing, and not for at home testing, in compliance with Section IV.D. of the FDA’s Policy for COVID-19 Diagnostic Test. MAIN COMPONENTS •

Brand Name:ETG

Model Number:01

Place of Origin:China

CE FDA (Whole Blood) export Home Great Quality Rapid Test Kit COVID-19(SARS-COV-2)Antibody Test kit Factory direct one step Virus detection Diagnostic Reagent Produced test kit With CE ISO rapid diagnostic test kits Home Great Quality Rapid Test Kit

Brand Name:Lycome

Model Number:LC-RT01

Place of Origin:Shenzhen,Guangdong

... antigen in a test device from nasal swab, throat swab or nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza SARS-CoV-2 viral infections. This test provides only a preliminary test result. Therefore, any

Brand Name:OEM

Place of Origin:China

... allow the sample to fully melt at room temperature (20-30 ° C), and mix the sample upside down before use. 3. Before starting the test, remove the test strip from the aluminum foil bag, lay it flat on the table, and mark the sample number. 4. Use a