FDA Device Establishments · JSON-LD · Markdown
FEI 1000087290 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 1000087290 |
|---|---|
| Owner / Operator | Thermo Fisher Scientific (#2517925) |
| Address | 75 Panorama Creek Dr, Rochester, NY, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | NNI |
| Regulation § (21 CFR) | 864.3250 |
| Proprietary names | Samco Clicktainer Vials, NS, 120ml, 53mm, with label, ORG Cap (Cat. No. 120ORG53-2000); Samco Bio-Tite Narrow Mouth, NS 90mL, 48mm, no lab, YEL Cap (Cat. No. 02 0147); Samco Bio-Tite Narrow Mouth, NS 40ml, 48mm, no lab , WHT Cap (Cat. No. 04 0181); Samco UrineGUARD Container 3500mL, 24hr (Cat. No. 30 3500); Samco Bio-Tite Wide Mouth, NS 120mL, 53mm, no lab, RED Cap (Cat. No. 01 0196); Samco Bio-Tite, NS, 20ml, 35mm, no lab, WHT Cap (Cat. No. 06 0181); Samco UrineGUARD Container 3000mL, 24hr (Cat. No. 30 3000); 2500ML 24 HR URINE CONTAINER (Cat. No. U3010-1); Samco Bio-Tite Wide Mouth, NS 120mL, 53mm, no lab, WHT Cap (Cat. No. 01 0181); Samco Bio-Tite Wide Mouth, NS 90mL, 53mm, w/lab, YEL Cap (Cat. No. 02 1105) |
Source: openFDA. Public-domain (CC0).