FDA Device Establishments · JSON-LD · Markdown
FEI 1220394 · Manufacture Medical Device · Status: Active
| FEI Number | 1220394 |
|---|---|
| Owner / Operator | LGC Clinical Diagnostics, Inc. (#9041170) |
| Address | 37 Birch St, Milford, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JJY |
| Regulation § (21 CFR) | 862.1660 |
| Proprietary names | VALIDATE Body Fluids 2 Calibration Verification/Linearity Test Kit, product code: 206ro; VALIDATE UC5 Calibration Verification/Linearity Test Kit, product code: 705ab; VALIDATE UC1 Calibration Verification/Linearity Test Kit, product code: 701ab, 701re, 701sa; VALIDATE Body Fluids Calibration Verification/Linearity Test Kit, product codes: 205bf, 205ro; VALIDATE Fertility 3 Calibration Verification/Linearity Test Kit, product code: 505ro; VALIDATE Fertility 1 Calibration Verification/Linearity Test Kit, product code: 502ab, 502re; VALIDATE THY2 Hormone Calibration Verification/Linearity Test Kit, product code:908bc; VALIDATE Diabetes Calibration Verification/Linearity Test Kit, product code: 204ro; VALIDATE® CM2 Calibration Verification / Linearity Test Set (Product Code 402pf); VALIDATE IBC Calibration Verification/Linearity Test Kit, product codes: 203ro, 203sd, 203vt |
Source: openFDA. Public-domain (CC0).