FDA Device Establishments · JSON-LD · Markdown
FEI 3011926203 · Manufacture Medical Device · Status: Active
| FEI Number | 3011926203 |
|---|---|
| Owner / Operator | Bio-Rad Laboratories, Inc. (#9929003) |
| Address | 100 South Jones Street Suite #100, Fort Worth, TX, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JIT |
| Regulation § (21 CFR) | 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] |
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