Model : SCLH 7+4, SCLH 4+4, SCLH 7, SCLH 4, CI700+700+700, CI 700+700, CI 700+500, CI 500+500, CI 700, CI 500

FDA registration

COGNATE INDIA·1 product·🇮🇳 India

Underpads

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Ucanrely New Medical Technology (Wei hai) Co., Ltd.·20 devices

Adult Diapers

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Ucanrely New Medical Technology (Wei hai) Co., Ltd.·17 devices

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330851·L-DFA Influenza A/Influenza B Reagent

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330752·D3 FASTPOINT RESP VIRUS ID KIT

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330776·D3 FASTPOINT LDFA VIR IDKIT BX

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330875·L-DFA Parainfluenza Virus/Adenovirus Reagent

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330769·D3 FASTPOINT LDFA VIR IDKIT BX

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330868·L-DFA RSV/MPV Reagent

D3 Fastpoint

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613330844·Re-Suspension Buffer

Antiserum, Hai, Rubeola

FDA classification

FDA Class 1 ·Antiserum, Hai, Rubeola

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

Test, Immunoassay, Biosensor, Hcg

FDA classification

FDA Class 2 ·Test, Immunoassay, Biosensor, Hcg

Antiserum, Hai, Mumps Virus

FDA classification

FDA Class 1 ·Antiserum, Hai, Mumps Virus

HBI Health & Beauty International GmbH

Importer

🇩🇪 Germany

Mask, Surgical, Eua Authorized

FDA classification

FDA Not Classified ·Mask, Surgical, Eua Authorized

Antisera, Hai, Reovirus 1-3

FDA classification

FDA Class 1 ·Antisera, Hai, Reovirus 1-3

Antisera, Hai, Adenovirus 1-33

FDA classification

FDA Class 1 ·Antisera, Hai, Adenovirus 1-33