DEX
5 FDA 510(k) clearances · Product code
31 daysmedian time to decision
56 days90th percentile
5clearances measured
FDA profile
- Official device name
- Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5420
- Medical specialty
- Immunology
- Adverse events (MAUDE)
- 2004: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ANTI SERA TO HUMAN OROSCOMUCOID (K823765) | Kent Laboratories, Inc. | 1982-12-30 |
| LSA 290 ASSAY REAGENTS/NEPHELOMETRIC (K801909) | J.T. Baker Chemical Co. | 1980-09-26 |
| HUMAN ALPHA, ACID GLYCOPROTEIN (K791341) | Beckman Instruments, Inc. | 1979-08-16 |
| ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU (K781023) | Icl Scientific | 1978-08-14 |
| SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN (K760143) | Oxford Laboratories, Inc. | 1976-07-20 |
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Every clearance here is in the API, with alerts when new ones post.