ADX TM OPIATES
Device Facts
| Record ID | K890689 |
|---|---|
| Device Name | ADX TM OPIATES |
| Applicant | Abbott Laboratories |
| Product Code | DGJ · Immunology |
| Decision Date | Aug 25, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5230 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A colostrum immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific proteins in colostrum. Colostrum is a substance excreted by the mammary glands during pregnancy and until production of breast milk begins 1 to 5 days after childbirth.
