BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

Calibrator Kit - PSA

FDA UDI

QUALIGEN INC.·00816467020020·

Renamic PSA Module

FDA UDI

BIOTRONIK SE & Co. KG·04035479126391·

Elecsys total PSA

FDA UDI

Roche Diagnostics GmbH·07613336165980·

Elecsys total PSA

FDA UDI

Roche Diagnostics GmbH·07613336166000·

Elecsys total PSA

FDA UDI

Roche Diagnostics GmbH·07613336165997·

total PSA CalCheck

FDA UDI

Roche Diagnostics GmbH·04015630995424·

Access Hybritech PSA

FDA UDI

Beckman Coulter, Inc.·H628372001·The Access Hybritech PSA assay is a paramagneti...

Elecsys total PSA

FDA UDI

Roche Diagnostics GmbH·04015630939824·

Novocastra

FDA UDI

LEICA BIOSYSTEMS NEWCASTLE LTD·05055331335746·NCL-L-PSA-431-U is intended for the qualitative...

Novocastra™

FDA UDI

LEICA BIOSYSTEMS NEWCASTLE LTD·05055331325723·NCL-L-PSA-431 is intended for the qualitative i...

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·Elecsys free PSA, free PSA CalSet, and free PSA CalCheck

MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

PSA Custom Control Levels 1, 2 and 3, IAC129, IAC130, IAC131

FDA registration

RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom

PSA Custom Control Levels 1, 2 and 3, IAC129, IAC130, IAC131

FDA registration

RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY

IMMULITE 2000 3RD GENERATION PSA

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION PSA FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS PSA (ON ELECSYS 1010)

FDA 510(k)

FDA Class 2 ·Immunology