TBD AT-HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HCG PREGNANCY ONE STEP TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RECAP

FDA 510(k)

FDA Class 2 ·Hematology

CLEARBLUE EASY DIGITAL PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNTRON BIORESEARCH U-TEST PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECSYS AFP

FDA 510(k)

FDA Class 2 ·Immunology

LIA Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSOM CARD PREGNANCY TEST, MODEL 103

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HOSPITAL LAB IN-HOME EARLY PREG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Distinct® Early Detection Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEARPLAN EASY II HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FACTPLUS ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV ASSAY, ABBOTT REALTIME HCV CALIBRATOR KIT, ABBOTT REALTIME HCV CONTROL KIT, ABBOTT MSAMPLE PREPARATI

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP