FUSION 7D

FDA 510(k)

FDA Class 2 ·Radiology

cobas® PCR Urine Sample Kit

FDA UDI

Roche Molecular Systems, Inc.·00875197002898·

Platelet PGDprime Processing Tubes

FDA UDI

Verax Biomedical Incorporated·10850046056090·Platelet PGDprime Processing Tubes are required...

Platelet PGDprime Reagents, 100 Test

FDA UDI

Verax Biomedical Incorporated·10850046056137·Platelet PGDprime Test Reagents required for pr...

APTIMA

FDA UDI

Hologic, Inc.·15420045506244·

Platelet PGDprime Sample Pipettes, Processing Tubes and Transfer Pipettes

FDA UDI

Verax Biomedical Incorporated·10850046056120·Platelet PGDprime Test System required disposab...

Platelet PGDprime Reagents, 20 Test

FDA UDI

Verax Biomedical Incorporated·10850046056144·Platelet PGDprime Reagents required to perform ...

Xpert Urine Specimen Collection Kit

FDA UDI

CEPHEID·07332940002954·Xpert Urine Specimen Collection Kit; 50 pack

Platelet PGDprime Controls

FDA UDI

Verax Biomedical Incorporated·10850046056151·Platelet PGDprime Positive and Negative Control...

Platelet PGDprime Test

FDA UDI

Verax Biomedical Incorporated·10850046056007·Platelet PGDprime Test single device pouch

Visby Medical Sexual Health Click Test

FDA UDI

Visby Medical, Inc.·00810031720002·Visby Medical Sexual Health Click Test

Gonochek®-II Reagent Tubes

FDA UDI

E-Y Laboratories, Inc.·00863251000218·Gonochek®-II is intended for the use in the det...

Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack

FDA UDI

Visby Medical, Inc.·00810031720057·Visby Medical Sexual Health Vaginal Specimen Co...

Platelet PGDprime Reagent 1B

FDA UDI

Verax Biomedical Incorporated·10850046056021·Platelet PGDprime Reagent 1B required for proce...

Platelet PGDprime Positive Control

FDA UDI

Verax Biomedical Incorporated·10850046056045·Platelet PGDprime Positive Control for quality ...

BD ProbeTec™ Urine Preservative Transport

FDA UDI

BECTON, DICKINSON AND COMPANY·30382904409280·Tube Urine Preservation Transport

Urine Preservative Transport for the BD ProbeTec™ Qx Amplified DNA Assays

FDA UDI

BECTON, DICKINSON AND COMPANY·30382904413621·Urine Preservative Transport for the BD ProbeTe...

Aptima®

FDA UDI

Hologic, Inc.·15420045511880·Aptima® Specimen Transfer Kit, 100 test.

Visby Medical Sexual Health Test

FDA UDI

Visby Medical, Inc.·00810031720064·

Platelet PGDprime Transfer Pipettes

FDA UDI

Verax Biomedical Incorporated·10850046056083·Platelet PGDprime Transfer Pipettes required to...