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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBeAg

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBcAg

BE19/819943491

Certificate

MDD Annex II (excluding section 4)·IQ Messenger B.V·SGS Belgium NV·1 Basic UDI-DI

2114129CE01

Certificate

IVDD Annex IV (excluding sections 4, 6)·IQ Products BV·DEKRA Certification B.V.·1 Basic UDI-DI

2114921

Certificate

IVDD Annex IV (excluding sections 4, 6)·IQ Products BV·DEKRA Certification B.V.·1 Basic UDI-DI

Babesia Spp. Serological Reagents

FDA classification

FDA Not Classified ·Babesia Spp. Serological Reagents

Bartonella Spp. Serological Reagents

FDA classification

FDA Not Classified ·Bartonella Spp. Serological Reagents

Orientia Spp. (Scrub Typhus) Serological Reagents

FDA classification

FDA Not Classified ·Orientia Spp. (Scrub Typhus) Serological Reagents

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA classification

FDA Class 3 ·Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

Igm (Mu Chain Specific), Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Igm (Mu Chain Specific), Antigen, Antiserum, Control

Hepatitis A Test (Antibody And Igm Antibody)

FDA classification

FDA Class 2 ·Hepatitis A Test (Antibody And Igm Antibody)

Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

FDA classification

FDA Not Classified ·Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

FDA classification

FDA Not Classified ·Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·VIDAS TOTAL PSA

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS FREE PSA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech PSA

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE