Manufacturer's Devices - Getein Biotech Inc.

Address:




No.9 Bofu Road Luhe District



Nanjing

211505

China


Authorised Representative/ UK Responsible Person
Name: CMC Medical Devices LTD
Address:

Office 32 19-21 Crawford Street



London

W1H 1PJ

United Kingdom




Code/Term Type
Fluorescent immunoassay analyser IVD laboratoryFluorescent immunoassay analyser IVD laboratoryIVD General
Chemiluminescent immunoassay analyser IVDChemiluminescent immunoassay analyser IVDIVD General
D-dimer IVD kit chemiluminescent immunoassayD-dimer IVD kit chemiluminescent immunoassayIVD General
Glycated haemoglobin (HbA1c) IVD kit chemiluminescent immunoassayGlycated haemoglobin (HbA1c) IVD kit chemiluminescent immunoassayIVD General
C-peptide IVD kit chemiluminescent immunoassayC-peptide IVD kit chemiluminescent immunoassayIVD General
Insulin antibody IVD kit chemiluminescent immunoassayInsulin antibody IVD kit chemiluminescent immunoassayIVD General
Insulin IVD kit chemiluminescent immunoassayInsulin IVD kit chemiluminescent immunoassayIVD General
C-reactive protein (CRP) IVD kit fluorescent immunoassayC-reactive protein (CRP) IVD kit fluorescent immunoassayIVD General
Procalcitonin (PCT) IVD kit fluorescent immunoassayProcalcitonin (PCT) IVD kit fluorescent immunoassayIVD General
Serum amyloid A IVD reagentSerum amyloid A IVD reagentIVD General
Interleukin-6 (IL-6) IVD reagentInterleukin-6 (IL-6) IVD reagentIVD General
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayIVD General
Luteinizing hormone (LH) IVD kit chemiluminescent immunoassayLuteinizing hormone (LH) IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 antigen IVD kit rapid ICT self-testingSARS-CoV-2 antigen IVD kit rapid ICT self-testingIVD Devices for Self-Testing
SARS-CoV-2 antigen IVD kit rapid ICT clinicalSARS-CoV-2 antigen IVD kit rapid ICT clinicalIVD General
Monkeypox virus antigen IVD kit rapid ICT clinicalMonkeypox virus antigen IVD kit rapid ICT clinicalIVD General
Anti-Mullerian hormone (AMH) IVD controlAnti-Mullerian hormone (AMH) IVD controlIVD General
C-reactive protein (CRP) IVD kit rapid ICT clinicalC-reactive protein (CRP) IVD kit rapid ICT clinicalIVD General
Total triiodothyronine (TT3) IVD controlTotal triiodothyronine (TT3) IVD controlIVD General
Total thyroxine (TT4) IVD controlTotal thyroxine (TT4) IVD controlIVD General
Procalcitonin (PCT) IVD kit rapid ICT clinicalProcalcitonin (PCT) IVD kit rapid ICT clinicalIVD General
Buffered sample diluent IVD automated/semi-automated systemBuffered sample diluent IVD automated/semi-automated systemIVD General
Nephelometry immunoassay analyser IVDNephelometry immunoassay analyser IVDIVD General
Fluorescent immunoassay analyser IVD laboratory semi-automatedFluorescent immunoassay analyser IVD laboratory semi-automatedIVD General
Carcinoembryonic antigen (CEA) IVD kit rapid ICT clinicalCarcinoembryonic antigen (CEA) IVD kit rapid ICT clinicalIVD General
Faecal occult blood IVD kit rapid ICT clinicalFaecal occult blood IVD kit rapid ICT clinicalIVD General
Multiple form 25-hydroxy Vitamin D IVD controlMultiple form 25-hydroxy Vitamin D IVD controlIVD General
Free triiodothyronine (FT3) IVD controlFree triiodothyronine (FT3) IVD controlIVD General
Prolactin IVD controlProlactin IVD controlIVD General
Progesterone IVD controlProgesterone IVD controlIVD General
Procalcitonin (PCT) IVD controlProcalcitonin (PCT) IVD controlIVD General
Luteinizing hormone (LH) IVD kit rapid ICT clinicalLuteinizing hormone (LH) IVD kit rapid ICT clinicalIVD General
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemIVD General
Microalbumin IVD kit rapid ICT clinicalMicroalbumin IVD kit rapid ICT clinicalIVD General
Multiple form 25-hydroxy vitamin D IVD kit rapid ICT clinicalMultiple form 25-hydroxy vitamin D IVD kit rapid ICT clinicalIVD General
Monkeypox virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinicalMonkeypox virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinicalIVD General
Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Total thyroxine (TT4) IVD kit rapid ICT clinicalTotal thyroxine (TT4) IVD kit rapid ICT clinicalIVD General
Total triiodothyronine (TT3) IVD kit rapid ICT clinicalTotal triiodothyronine (TT3) IVD kit rapid ICT clinicalIVD General
Follicle stimulating hormone (FSH) IVD kit rapid ICT clinicalFollicle stimulating hormone (FSH) IVD kit rapid ICT clinicalIVD General
Serum amyloid A IVD kit chemiluminescent immunoassaySerum amyloid A IVD kit chemiluminescent immunoassayIVD General
Cystatin C IVD kit rapid ICT clinicalCystatin C IVD kit rapid ICT clinicalIVD General
Glycated haemoglobin (HbA1c) IVD kit rapid ICT clinicalGlycated haemoglobin (HbA1c) IVD kit rapid ICT clinicalIVD General
Serum amyloid A IVD kit rapid ICT clinicalSerum amyloid A IVD kit rapid ICT clinicalIVD General
Thyroid stimulating hormone (TSH) IVD kit rapid ICT clinicalThyroid stimulating hormone (TSH) IVD kit rapid ICT clinicalIVD General
Free thyroxine (FT4) IVD kit rapid ICT clinicalFree thyroxine (FT4) IVD kit rapid ICT clinicalIVD General
Free triiodothyronine (FT3) IVD kit rapid ICT clinicalFree triiodothyronine (FT3) IVD kit rapid ICT clinicalIVD General
Prolactin IVD kit rapid ICT clinicalProlactin IVD kit rapid ICT clinicalIVD General
Alpha-fetoprotein (AFP) IVD kit rapid ICT clinicalAlpha-fetoprotein (AFP) IVD kit rapid ICT clinicalIVD General
Multiple cardiac marker IVD kit rapid ICT clinicalMultiple cardiac marker IVD kit rapid ICT clinicalIVD General
Multiple thyroid marker IVD controlMultiple thyroid marker IVD controlIVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit immunochromatographic test (ICT) rapidHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit immunochromatographic test (ICT) rapidIVD General
Troponin I IVD controlTroponin I IVD controlIVD General
Troponin I IVD kit rapid ICT clinicalTroponin I IVD kit rapid ICT clinicalIVD General
Creatine kinase myocardial isoenzyme (CKMB) IVD controlCreatine kinase myocardial isoenzyme (CKMB) IVD controlIVD General
Glycated haemoglobin (HbA1c) IVD controlGlycated haemoglobin (HbA1c) IVD controlIVD General
Ferritin IVD controlFerritin IVD controlIVD General
Fatty acid binding protein (FABP) IVD controlFatty acid binding protein (FABP) IVD controlIVD General
C-reactive protein (CRP) IVD controlC-reactive protein (CRP) IVD controlIVD General
Myoglobin IVD controlMyoglobin IVD controlIVD General
Thyroid stimulating hormone (TSH) IVD controlThyroid stimulating hormone (TSH) IVD controlIVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD controlHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD controlIVD General
Free thyroxine (FT4) IVD controlFree thyroxine (FT4) IVD controlIVD General
Follicle stimulating hormone (FSH) IVD controlFollicle stimulating hormone (FSH) IVD controlIVD General
Luteinizing hormone (LH) IVD controlLuteinizing hormone (LH) IVD controlIVD General
Faecal occult blood IVD controlFaecal occult blood IVD controlIVD General
Beta-2-microglobulin IVD controlBeta-2-microglobulin IVD controlIVD General
Total immunoglobulin E (IgE total) IVD controlTotal immunoglobulin E (IgE total) IVD controlIVD General
Haematological cell analyser IVDHaematological cell analyser IVDIVD General
Troponin T IVD kit rapid ICT clinicalTroponin T IVD kit rapid ICT clinicalIVD General
Multiple cardiac marker IVD controlMultiple cardiac marker IVD controlIVD General
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit rapid ICT clinicalB-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit rapid ICT clinicalIVD General
Troponin T IVD controlTroponin T IVD controlIVD General
Interleukin-6 (IL-6) IVD controlInterleukin-6 (IL-6) IVD controlIVD General
Microalbumin IVD controlMicroalbumin IVD controlIVD General
Serum amyloid A IVD controlSerum amyloid A IVD controlIVD General
Creatine kinase myocardial isoenzyme (CKMB) IVD kit rapid ICT clinicalCreatine kinase myocardial isoenzyme (CKMB) IVD kit rapid ICT clinicalIVD General
Blood cell preservation/storage/dilution solution IVDBlood cell preservation/storage/dilution solution IVDIVD General
Treponema pallidum total antibody IVD kit rapid ICT clinicalTreponema pallidum total antibody IVD kit rapid ICT clinicalIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalBeta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalIVD General
Helicobacter pylori antigen IVD controlHelicobacter pylori antigen IVD controlIVD General
Influenza virus/respiratory syncytial virus (RSV) antigen IVD kit immunochromatographic test (ICT) rapidInfluenza virus/respiratory syncytial virus (RSV) antigen IVD kit immunochromatographic test (ICT) rapidIVD General
Cystatin C IVD controlCystatin C IVD controlIVD General
Neutrophil gelatinase-associated lipocalin (NGAL) IVD controlNeutrophil gelatinase-associated lipocalin (NGAL) IVD controlIVD General
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD controlB-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD controlIVD General
D-dimer IVD controlD-dimer IVD controlIVD General
D-dimer IVD kit rapid ICT clinicalD-dimer IVD kit rapid ICT clinicalIVD General
Fluorescent immunoassay analyser IVD point-of-care battery-poweredFluorescent immunoassay analyser IVD point-of-care battery-poweredIVD General
Helicobacter pylori antigen IVD kit rapid ICT clinicalHelicobacter pylori antigen IVD kit rapid ICT clinicalIVD General