ANA/HEp-2 IgG IFA 1200 Test

FDA UDI

Hemagen Diagnostics, Inc.·G5229023701·For the detection and titration of anti-nuclear...

ANA/HEp-2 IgG IFA 600 Test

FDA UDI

Hemagen Diagnostics, Inc.·G5229023601·For the detection and titration of anti-nuclear...

QUANTA Lite® h-tTG IgG ELISA

FDA UDI

INOVA DIAGNOSTICS, INC.·08426950456131·(Human Tissue Transglutaminase) 1. 1x ANA ELISA...

ANA/HEp-2 IgG IFA 180 Test

FDA UDI

Hemagen Diagnostics, Inc.·G5229023451·For the detection and titration of anti-nuclear...

Borrelia B31 IgG ViraBlot® Test Kit

FDA UDI

Viramed Biotech AG·EVIRBBBGUS1·Westernblot-assay for the detection of IgG anti...

Autostat II Anti-B2-Glycoprotein I IgG

FDA UDI

HYCOR BIOMEDICAL LLC·00816879020229·96 well ELISA for the detection of Anti-B2-Glyc...

HemosIL AcuStar Anti-B2 Glycoprotein-I IgG

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·08426950496977·HemosIL AcuStar Anti-B2 Glycoprotein-I IgG

BioPlex 2200 MMRV IgG

FDA registration

Bio-Rad Laboratories, Inc.·4 products·🇺🇸 United States

BioPlex 2200 MMRV IgG

FDA registration

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

BioPlex 2200 MMRV IgG

FDA registration

Bio-Rad Laboratories, Inc.·4 products·🇺🇸 United States

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

CLEARVIEW HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)

FDA 510(k)

FDA Class 1 ·Immunology

CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TURBOX FIBRINOGEN

FDA 510(k)

FDA Class 2 ·Hematology

CLEARVIEW STREP A

FDA 510(k)

FDA Class 1 ·Microbiology

TURBOX

FDA 510(k)

FDA Class 1 ·Immunology

STAPHYTECT-OD

FDA 510(k)

FDA Class 1 ·Microbiology

CLEARPLAN

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CLEARVIEW HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry