High Range Urine Metals 12110
High Range Urine Metals 12110 is a multiple heavy metal IVD (FDA Class I; FDA product code LAS, Drug Specific Control Materials) made by UTAK Laboratories Inc., listed in FDA GUDID since 15 Apr 2020 (UDI-DI B800121100), 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 | NumberB800121100 | Date15 Apr 2020 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- High Range Urine Metals
- Generic name
- Multiple heavy metal IVD, control
- Model / Ref / Catalog
- 12110
- Primary DI / UDI-DI
- B800121100
- FDA product code
- LAS
- GMDN term
- Multiple heavy metal IVD, control
- Device class
- Class I
- Regulation number
- 862.3280
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 5 Milliliter
From the manufacturer
Manufacturer's product page: AED II (High Range)72740
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