QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-LKM-1 ELISA(LGG)

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE LKM-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELEOSx™ Limb Salvage System

FDA 510(k)

FDA Class 2 ·Orthopedic

Gas Chromatography, Salicylate

FDA classification

FDA Class 2 ·Gas Chromatography, Salicylate

Tubes, Vacuum Sample, With Anticoagulant

FDA classification

FDA Class 2 ·Tubes, Vacuum Sample, With Anticoagulant

Voltage Gated Calcium Channel (Vgcc) Antibody Assay

FDA classification

FDA Class 2 ·Voltage Gated Calcium Channel (Vgcc) Antibody Assay

Sleeve, Limb, Compressible

FDA classification

FDA Class 2 ·Sleeve, Limb, Compressible

External Upper Limb Tremor Stimulator

FDA classification

FDA Class 2 ·External Upper Limb Tremor Stimulator

Device, Warning, Overload, External Limb, Powered

FDA classification

FDA Class 2 ·Device, Warning, Overload, External Limb, Powered

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

FDA Pre-Market Approval

FDA Class 2 ·CA 125 ANTIBODY RIA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·AIA-PACK PA PSA, ST AIA-PACK PA PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM/TOTAL PSA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA