Manufacturer's Devices - VivaChek Biotech (Hangzhou) Co. Ltd.

Address:




Level 2 Block 2 146 East Chaofeng Rd. Yuhang Economy Development Zone



Hangzhou

Zhejiang 311100

China


Authorised Representative/ UK Responsible Person
Name: lotus global co ltd
Address:

23 Maine Street



Reading

Reading RG2 6AG

England United Kingdom




Code/Term Type
SARS-CoV-2 neutralizing antibody IVD kit fluorescent immunoassay rapidSARS-CoV-2 neutralizing antibody IVD kit fluorescent immunoassay rapidIVD General
Fluorescent immunoassay analyser IVD point-of-care line-poweredFluorescent immunoassay analyser IVD point-of-care line-poweredIVD General
SARS-CoV-2 neutralizing antibody IVD kit rapid ICT clinicalSARS-CoV-2 neutralizing antibody IVD kit rapid ICT clinicalIVD General
Glucose IVD reagentGlucose IVD reagentIVD Annex II List B
Glucose IVD controlGlucose IVD controlIVD Annex II List B
Ketone (acetoacetate) IVD reagentKetone (acetoacetate) IVD reagentIVD Devices for Self-Testing
Ketone (acetoacetate) IVD controlKetone (acetoacetate) IVD controlIVD Devices for Self-Testing
Glucose/ketone monitoring system IVD home-useGlucose/ketone monitoring system IVD home-useIVD Annex II List B
Multiple clinical chemistry analyte monitoring system IVD point-of-careMultiple clinical chemistry analyte monitoring system IVD point-of-careIVD Devices for Self-Testing
Uric acid IVD reagentUric acid IVD reagentIVD Devices for Self-Testing
Uric acid IVD controlUric acid IVD controlIVD Devices for Self-Testing
Glucose monitoring system IVD home-useGlucose monitoring system IVD home-useIVD Annex II List B
Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Haemoglobin analyser IVD point-of-careHaemoglobin analyser IVD point-of-careIVD General
Haemoglobin detection IVD reagentHaemoglobin detection IVD reagentIVD General
Haemoglobin detection IVD controlHaemoglobin detection IVD controlIVD General
Creatine kinase myocardial isoenzyme (CKMB) IVD kit fluorescent immunoassayCreatine kinase myocardial isoenzyme (CKMB) IVD kit fluorescent immunoassayIVD General
Multiple cardiac marker IVD kit fluorescent immunoassayMultiple cardiac marker IVD kit fluorescent immunoassayIVD General
Troponin I IVD kit fluorescent immunoassayTroponin I IVD kit fluorescent immunoassayIVD General
Cystatin C IVD reagentCystatin C IVD reagentIVD General
D-dimer IVD kit fluorescent immunoassayD-dimer IVD kit fluorescent immunoassayIVD General
Glycated haemoglobin (HbA1c) IVD kit rapid ICT clinicalGlycated haemoglobin (HbA1c) IVD kit rapid ICT clinicalIVD General
Fatty acid binding protein (FABP) IVD reagentFatty acid binding protein (FABP) IVD reagentIVD General
C-reactive protein (CRP) IVD kit fluorescent immunoassayC-reactive protein (CRP) IVD kit fluorescent immunoassayIVD General
Luteinizing hormone (LH) IVD kit rapid ICT clinicalLuteinizing hormone (LH) IVD kit rapid ICT clinicalIVD General
Myoglobin IVD kit fluorescent immunoassayMyoglobin IVD kit fluorescent immunoassayIVD General
Neutrophil gelatinase-associated lipocalin (NGAL) IVD kit fluorescent immunoassayNeutrophil gelatinase-associated lipocalin (NGAL) IVD kit fluorescent immunoassayIVD General
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit fluorescent immunoassayB-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit fluorescent immunoassayIVD General
Procalcitonin (PCT) IVD kit fluorescent immunoassayProcalcitonin (PCT) IVD kit fluorescent immunoassayIVD General
Serum amyloid A IVD kit rapid ICT clinicalSerum amyloid A IVD kit rapid ICT clinicalIVD General
Multiple Plasmodium species antigen IVD kit rapid ICT clinicalMultiple Plasmodium species antigen IVD kit rapid ICT clinicalIVD General
Interleukin-6 (IL-6) IVD reagentInterleukin-6 (IL-6) IVD reagentIVD General
Ketamine/ketamine metabolite IVD reagentKetamine/ketamine metabolite IVD reagentIVD General
Microalbumin IVD kit rapid ICT clinicalMicroalbumin IVD kit rapid ICT clinicalIVD General
Beta-2-microglobulin IVD reagentBeta-2-microglobulin IVD reagentIVD General
Troponin T IVD kit fluorescent immunoassayTroponin T IVD kit fluorescent immunoassayIVD General
Total human chorionic gonadotropin (HCG) IVD kit fluorescent immunoassayTotal human chorionic gonadotropin (HCG) IVD kit fluorescent immunoassayIVD General
Thyroid stimulating hormone (TSH) IVD kit fluorescent immunoassayThyroid stimulating hormone (TSH) IVD kit fluorescent immunoassayIVD General
Total triiodothyronine (TT3) IVD kit fluorescent immunoassayTotal triiodothyronine (TT3) IVD kit fluorescent immunoassayIVD General
Total thyroxine (TT4) IVD kit fluorescent immunoassayTotal thyroxine (TT4) IVD kit fluorescent immunoassayIVD General
Anti-Mullerian hormone (AMH) IVD reagentAnti-Mullerian hormone (AMH) IVD reagentIVD General
Follicle stimulating hormone (FSH) IVD reagentFollicle stimulating hormone (FSH) IVD reagentIVD General
Prolactin IVD kit fluorescent immunoassayProlactin IVD kit fluorescent immunoassayIVD General
Estrone-3-glucuronide IVD reagentEstrone-3-glucuronide IVD reagentIVD General
Progesterone IVD reagentProgesterone IVD reagentIVD General
Total testosterone IVD reagentTotal testosterone IVD reagentIVD General
Free thyroxine (FT4) IVD reagentFree thyroxine (FT4) IVD reagentIVD General
Free triiodothyronine (FT3) IVD reagentFree triiodothyronine (FT3) IVD reagentIVD General
Alpha-fetoprotein (AFP) IVD kit fluorescent immunoassayAlpha-fetoprotein (AFP) IVD kit fluorescent immunoassayIVD General
Carcinoembryonic antigen (CEA) IVD kit fluorescent immunoassayCarcinoembryonic antigen (CEA) IVD kit fluorescent immunoassayIVD General
Faecal occult blood IVD reagentFaecal occult blood IVD reagentIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalBeta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalIVD General
C-reactive protein (CRP) IVD kit rapid ICT clinicalC-reactive protein (CRP) IVD kit rapid ICT clinicalIVD General
Treponema pallidum antigen IVD kit rapid ICT clinicalTreponema pallidum antigen IVD kit rapid ICT clinicalIVD General
Helicobacter pylori antigen IVD kit rapid ICT clinicalHelicobacter pylori antigen IVD kit rapid ICT clinicalIVD General
Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinicalRespiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinicalIVD General
Adenovirus antigen IVD kit rapid ICT clinicalAdenovirus antigen IVD kit rapid ICT clinicalIVD General
Multiple gastrointestinal virus antigen IVD kit rapid ICT clinicalMultiple gastrointestinal virus antigen IVD kit rapid ICT clinicalIVD General
Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidTotal human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidIVD General
Faecal occult blood IVD kit rapid ICT clinicalFaecal occult blood IVD kit rapid ICT clinicalIVD General
Dengue virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalDengue virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalIVD General
Dengue virus antigen IVD kit rapid ICT clinicalDengue virus antigen IVD kit rapid ICT clinicalIVD General
Dengue virus antigen/antibody IVD kit rapid ICT clinicalDengue virus antigen/antibody IVD kit rapid ICT clinicalIVD General
Influenza A/B virus antigen IVD kit rapid ICT clinicalInfluenza A/B virus antigen IVD kit rapid ICT clinicalIVD General
Rotavirus antigen IVD kit rapid ICT clinicalRotavirus antigen IVD kit rapid ICT clinicalIVD General