Contract manufacturerNalge Nunc International Corporation (Rochester, NY)New YorkPathologyMicrobiologyClass I
Nalge Nunc International Corporation
Contract manufacturer · Rochester, NY
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1314344 (openFDA record; or search FDA's registration database)
- FEI number
- 1000087290
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer
- Owner or operator
- Thermo Fisher Scientific (FDA owner/operator no. 2517925)
- Registered address
- 75 Panorama Creek Dr, Rochester, NY 14625
- Contract listings
- 4 device listings, 4 product codes, first listed Aug 27, 2001
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| FMH | Container, Specimen, Sterile | Class I | Pathology | Contract manufacturing | Aug 27, 2001 |
| KZJ | Device, Gas Generating | Class I | Microbiology | Contract manufacturing | Aug 25, 2015 |
| NNI | Container, Specimen, Non-Sterile | Class I | Pathology | Contract manufacturing | Nov 13, 2006 |
| NNL | Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile | Class I | Pathology | Contract manufacturing | Mar 26, 2004 |