Immunalysis 10009-5
Immunalysis 10009-5 is an opiate/opiate metabolite IVD (FDA Class II; FDA product code DLJ, Calibrators, Drug Specific) made by Immunalysis Corporation, listed in FDA GUDID since 13 Sep 2016 (UDI-DI 00840937108314), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840937108314 | Date13 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00840937108314
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Immunalysis
- Generic name
- Opiate/opiate metabolite IVD, calibrator
- Model / Ref / Catalog
- 10009-5
- Primary DI / UDI-DI
- 00840937108314
- FDA product code
- DLJ
- GMDN term
- Opiate/opiate metabolite IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.3200
- GUDID distribution status
- In Commercial Distribution
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