BZF-29

FDA 510(k)

FDA Class 2 ·Dental

HAcancellous PEEK-C Porous HA PEEK Cervical IBF System

FDA registration

INNOVASIS, INC.·1 product·🇺🇸 United States

Fortilink Interbody Fusion (IBF) Device with TETRAfuse 3D Technology

FDA registration

Pioneer Surgical Technology, Inc.·2 products·🇺🇸 United States

IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF

FDA 510(k)

FDA Class 2 ·Orthopedic

Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System

FDA 510(k)

FDA Class 2 ·Orthopedic

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON COBAS E 601

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON COBAS E 411

ImmunoFA Toxoplasma IgM Conjugate

FDA UDI

Genbio·00613745013091·Conjugate for use with ImmunoFA Toxoplasma IgM ...

ImmunoFA 10x PBS

FDA UDI

Genbio·00613745010052·10-fold concentrate of 0.01M PBS

ImmunoFA Toxoplasma IgG

FDA UDI

Genbio·00613745012001·The ImmunoFA Toxo IgG Test is an immunofluoresc...

ImmunoFA Toxoplasma IgM Positive Control

FDA UDI

Genbio·00613745013411·Positive control for use with ImmunoFA Toxoplas...

ImmunoFA Toxoplasma IgM

FDA UDI

Genbio·00613745013008·The ImmunoFA Toxo IgM Test is an immunofluoresc...

Toxo IgG IFA 120 Test

FDA UDI

Hemagen Diagnostics, Inc.·G5229020101·For the detection and titration of Toxoplasma g...

Toxo IgG IFA 204 Test

FDA UDI

Hemagen Diagnostics, Inc.·G5229020201·For the detection and titration of Toxoplasma g...

ImmunoFA 10x PBS

FDA UDI

Genbio·00613745010069·10-fold concentrate of 0.01M PBS

ACCURUN®

FDA UDI

Lgc Clinical Diagnostics, Inc.·00816784020390·ACCURUN 135 Toxoplasma IgG 1 x 1.0 mL

ImmunoFA Toxoplasma IgG Conjugate

FDA UDI

Genbio·00613745012025·IgG conjugate for use with ImmunoFA Toxoplasma ...

ImmunoFA Toxoplasma Slides

FDA UDI

Genbio·00613745012070·For use with ImmunoFA Toxoplasma kits

ImmunoFA Toxoplasma Slides

FDA UDI

Genbio·00613745012018·Toxoplasma Slides for use with ImmunoFA Toxopla...