Real Time Nucleic Acid Amplification System (OOI) contract manufacturers
7 US facilities list FDA product code OOI as a contract manufacturer (7) or contract sterilizer (0).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Real Time Nucleic Acid Amplification System
- Product code
- OOI (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 862.2570
- Classification panel
- Clinical chemistry
Where they are
California 3 · Massachusetts 1 · Maine 1 · Ohio 1 · Texas 1
All 7 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| DIAMOND DIAGNOSTICS Inc | 3003030793 | Contract manufacturer | Microbiology; Clinical chemistry; Hematology | Holliston, MA | Not verified | Oct 21, 2026 |
| ENERCON TECHNOLOGIES | 3003018722 | Contract manufacturer | Gastroenterology and urology; Microbiology; Dental +5 more | Gray, ME | Not verified | Oct 21, 2026 |
| Planet Innovation Products, Inc. | 2022994 | Contract manufacturer | Microbiology; Clinical chemistry; General hospital +2 more | Irvine, CA | Not verified | Oct 21, 2026 |
| Sanmina | 3007867838 | Contract manufacturer | General and plastic surgery; Clinical chemistry; Ophthalmic +1 more | San Jose, CA | Not verified | Oct 21, 2026 |
| Sanmina Corporation | 3009609218 | Contract manufacturer | General hospital; Anesthesiology; Clinical chemistry | Carrollton, TX | Not verified | Oct 21, 2026 |
| TECAN CDMO SOLUTIONS MH, CORP. | 3003537036 | Contract manufacturer | Gastroenterology and urology; Clinical chemistry; General and plastic surgery +4 more | Morgan Hill, CA | Not verified | Oct 21, 2026 |
| VWR CHEMICALS, LLC | 1550222 | Contract manufacturer | Clinical chemistry; Microbiology; Pathology +3 more | Solon, OH | Not verified | Oct 21, 2026 |
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