# K973155: Ubi Magiwel Opiate Metabolites

- Pathway: 510(k) (Traditional)
- Applicant: United Biotech, Inc.
- Decided: Oct 28, 1997 after 67 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The UBI MAGIWEL™ Opiate metabolites is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Opiate metabolites in human urine. (for Professional use only)

Source page: https://510kreport.com/device/K973155
Methodology: https://510kreport.com/methodology