Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QuantiFERON-TB Gold and QuantiFERON -TB Gold Plus.

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval

FDA Class 3 ·T-SPOT ®.TB

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QuantiFERON - TB Gold Test and TB Gold Plus Test

CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421

FDA UDI

CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302021356·ETHA (Alcohol) w/ cal 3 x 375 tests

CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421

FDA UDI

CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302021370·ETHA (Alcohol) w/ cal 2 x 625 tests

CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421

FDA UDI

CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302021387·ETHA (Alcohol) w/ cal - UDR CX/LX/DXC 2 x 150 t...

CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421

FDA UDI

CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302021349·ETHA (Alcohol) w/ cal 2 x 100 tests

CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421

FDA UDI

CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302021332·ETHA (Alcohol) w/ cal 2 x 100 tests

CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321

FDA UDI

CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302021363·ETHA (Alcohol) w/ cal 2 x 300 tests

Glucose Oxidase, Glucose

FDA Pre-Market Approval

FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne®Liquid CDx (F1LCDx)

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·digene HC2 High-Risk HPB DNA Test and digene HC2 HPV DNA Test

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REAL TIME HBV CONTROL KIT

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Abbott RealTime HCV Genotype II Assay

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV ASSAY

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

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Carbomedics Prosthetic Heart Valve, Carbo-Seal Ascending Aortic Prosthesis, Carbo-Seal Valsalva Ascending Aortic Prosthe

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HBV CALIBRATOR KIT