Anti-Sm Antibody, Antigen And Control

FDA classification

FDA Class 2 ·Anti-Sm Antibody, Antigen And Control

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS

Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

FDA classification

FDA Class 2 ·Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

Norovirus Serological Reagent

FDA classification

FDA Class 2 ·Norovirus Serological Reagent

Hiv-1 Genotyping Assay Using Ngs Technology

FDA classification

FDA Class 2 ·Hiv-1 Genotyping Assay Using Ngs Technology

Complement 4d (C4d) And Complement Receptor 1 (Cr1)

FDA classification

FDA Class 2 ·Complement 4d (C4d) And Complement Receptor 1 (Cr1)

Anti-Factor Xa Activity Test System, Apixaban

FDA classification

FDA Class 2 ·Anti-Factor Xa Activity Test System, Apixaban

Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

FDA classification

FDA Class 2 ·Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

Dengue Serological Reagents

FDA classification

FDA Class 2 ·Dengue Serological Reagents

Second Antibody (Species Specific Anti-Animal Gamma Globulin)

FDA classification

FDA Class 2 ·Second Antibody (Species Specific Anti-Animal Gamma Globulin)

Corneal Storage Media With Preservatives Including Anti-Fungal

FDA classification

FDA Class 2 ·Corneal Storage Media With Preservatives Including Anti-Fungal

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV ON CENTAUR CP

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS

Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tester, Auditory Impedance, Exempt

FDA classification

FDA Class 2 ·Tester, Auditory Impedance, Exempt

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

FDA classification

FDA Class 2 ·Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab