BioPlex2200 APLS IgM Control Set

FDA registration

BIO-RAD LABORATORIES, INC.·4 products·🇺🇸 United States

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATION PSA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000/IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 Third Generation 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

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

Herpes Simplex Virus -Ⅱ IgM (HSV-Ⅱ IgM) Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·On the market

Herpes Simplex Virus -Ⅰ IgM (HSV-Ⅰ IgM) Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·On the market

Herpes Simplex Virus-Ⅱ IgG(HSV-Ⅱ IgG) Assay Reagent Kit(CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·On the market

Herpes Simplex Virus -Ⅰ IgG (HSV-Ⅰ IgG) Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·On the market

Herpes Simplex Virus -Ⅰ IgG (HSV-Ⅰ IgG) Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Cybereagen Biotech Co., Ltd.·On the market

Herpes Simplex Virus -II IgM (HSVII IgM) Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Cybereagen Biotech Co., Ltd.·On the market

Herpes Simplex Virus -Ⅱ IgG (HSV-Ⅱ IgG) Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Cybereagen Biotech Co., Ltd.·On the market

Herpes Simplex Virus -Ⅰ IgM (HSV-Ⅰ IgM) Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Cybereagen Biotech Co., Ltd.·On the market

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT IMX FREE PSA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT ARCHITECT TOTAL PSA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·VIDAS TOTAL PSA ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM/TOTAL PSA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Total PSA