# EXACT DIAGNOSTICS

FEI: 3011926203
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: Bio-Rad Laboratories, Inc. (#9929003)

Address: 100 South Jones Street Suite #100, Fort Worth, TX, US



## Products

Total registered: 1
Top product codes: JIT
Regulation §: 862.1150

Proprietary names: Exact Diagnostics HIV-1 1E3 cp/mL Precision [HIVL201], Exact Diagnostics BKV Verification Panel [BKVP100], Exact Diagnostics HIV-1 LOD [HIVLOD], Exact Diagnostics Zika Verification Panel [ZKVP100], Exact Diagnostics JCV Verification Panel [JCVP100], Exact Diagnostics HBV LOD [HBVLOD], Exact Diagnostics CMV Verification Panel 1.4 mL [CMVP200], Exact Diagnostics C. difficile Verification Panel [CDFP200], Exact Diagnostics HSV-1 Verification Panel [HSV1P100], Exact Diagnostics HCV 1E6 IU/mL Precision [HCVH202]

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223011926203%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3011926203