FDA Device Establishments · JSON-LD · Markdown
FEI 3004140393 · Manufacture Medical Device · Status: Active
| FEI Number | 3004140393 |
|---|---|
| Owner / Operator | BIOCARE HOLDINGS, LLC (#9058052) |
| Address | 60 Berry Drive, Pacheco, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | MVU |
| Regulation § (21 CFR) | 864.4020 |
| Proprietary names | HER2/neu [IHC042]; MYC (8q24) Green; CCND1 (11q13) Orange; Copy Control 6q11.1 Aqua; 20q13.2 Orange; Copy Control 12 Green; Copy Control 7 Green; HPV Type 11 Probe (Digoxigenin); Copy Control 15 Orange; 5p15.2 Red |
Source: openFDA. Public-domain (CC0).