Home › KAMIYA BIOMEDICAL COMPANY, LLC › K-ASSAY® Alpha-1 AT Reagent
K-ASSAY® Alpha-1 AT Reagent
KAMIYA BIOMEDICAL COMPANY, LLC · Model KAI-001 · UDI-DI 00816426020009
DEM
Prescription
1
510(k) clearances
4
Adverse events
1
Recalls
23
Facilities
Description
For the quantitative determination of human alpha-1 anti-trypsin (Alpha-1 AT) in serum by immunoturbidimetric assay.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-08-23 | The Binding Site Group, Ltd. | The high control for the kit is recovering low and may be out of range for assigned values. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.