Contract manufactureriHealth Manufacturing Inc (Irwindale, CA)CaliforniaMicrobiologyNot classifiedClass II
iHealth Manufacturing Inc
Contract manufacturer ยท Irwindale, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3023947183 (openFDA record; or search FDA's registration database)
- FEI number
- 3023947183
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- iHealth labs Inc (FDA owner/operator no. 10078949)
- Registered address
- 15715 Arrow Hwy, Irwindale, CA 91706, Irwindale, CA 91706
- Contract listings
- 3 device listings, 3 product codes, first listed Sep 10, 2022
- 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 |
|---|---|---|---|---|---|
| QKP | Coronavirus Antigen Detection Test System. | Not classified | Microbiology | Contract manufacturing | Sep 10, 2022 |
| QMN | Covid-19 Multi-Analyte Antigen Device | Not classified | Microbiology | Contract manufacturing | Sep 12, 2024 |
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | Class II | Microbiology | Contract manufacturing | Sep 14, 2026 |