Immunalysis 3020-15
Immunalysis 3020-15 is a Class I device made by Immunalysis Corporation, listed in FDA GUDID since 19 Apr 2024 (UDI-DI 00840937114674), 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 | Number00840937114674 | Date19 Apr 2024 | StatusListed |
Official records
- AccessGUDID record 00840937114674
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Immunalysis
- Generic name
- Opiate/opiate metabolite IVD, control
- Model / Ref / Catalog
- 3020-15
- Primary DI / UDI-DI
- 00840937114674
- FDA product code
- DIF
- GMDN term
- Opiate/opiate metabolite IVD, control
- Device class
- Class I
- Regulation number
- 862.3280
- GUDID distribution status
- In Commercial Distribution
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