Direct Lipid Control Set 3000
by Medtest DX
Direct Lipid Control Set 3000, a multiple lipid analyte IVD (FDA Class I; FDA product code JJY, Multi-Analyte Controls, All Kinds (Assayed)) made by Medtest DX, was listed in FDA GUDID on 27 Sep 2016 (UDI-DI 00817439020000); the registry lists it as not in commercial distribution (GUDID) as of 22 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 | Number00817439020000 | Date27 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00817439020000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Direct Lipid Control Set
- Generic name
- Multiple lipid analyte IVD, control
- Model / Ref / Catalog
- 3000
- Primary DI / UDI-DI
- 00817439020000
- FDA product code
- JJY
- GMDN term
- Multiple lipid analyte IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- Not in Commercial Distribution
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