Igg (Fd Fragment Specific), Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Igg (Fd Fragment Specific), Antigen, Antiserum, Control

Igg (Fab Fragment Specific), Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Igg (Fab Fragment Specific), Antigen, Antiserum, Control

Igg (Fc Fragment Specific), Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Igg (Fc Fragment Specific), Antigen, Antiserum, Control

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA classification

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

Igg (Gamma Chain Specific), Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Igg (Gamma Chain Specific), Antigen, Antiserum, Control

Triolab AS

Importer

🇳🇴 Norway·5 Manufacturers

Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

FDA classification

FDA Class 2 ·Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

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

Antibodies, Anti-Actin, Anti-Smooth Muscle

FDA classification

FDA Class 2 ·Antibodies, Anti-Actin, Anti-Smooth Muscle

Strip, Hama Igg, Elisa, In Vitro Test System

FDA classification

FDA Class 2 ·Strip, Hama Igg, Elisa, In Vitro Test System

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

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz

FDA 510(k)

FDA Class 2 ·Immunology

Anti-Phospholipase A2 Receptor

FDA classification

FDA Class 2 ·Anti-Phospholipase A2 Receptor

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

Anti-Ss-A Ro60 Autoantibodies

FDA classification

FDA Class 2 ·Anti-Ss-A Ro60 Autoantibodies

Eurolink Europe Compliance Limited

Authorized representative

🇮🇪 Ireland·35 Manufacturers·252 Devices

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR