Home › Device types › PEP
Molecular Erythrocyte Typing Test
FDA product code PEP · Class 3 · Unknown
9
Registered devices
261
Adverse events
1
Recalls
0
510(k) clearances
Devices with this code
Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Plate — BIOARRAY SOLUTIONS LTDFilled Vial,Negative Control 1mL — BIOARRAY SOLUTIONS LTDFilled Vial, Clean-up, 330uL — BIOARRAY SOLUTIONS LTDID CORE XT — PROGENIKA BIOPHARMA, SAFilled Vial, HEA 1.2 PCR Mix — BIOARRAY SOLUTIONS LTDFilled Vial,HotStarTaq DNA Polymerase — BIOARRAY SOLUTIONS LTDFilled Vial, Lambda Exonuclease — BIOARRAY SOLUTIONS LTDFilled Vial, eMAPTM Elongation Mix — BIOARRAY SOLUTIONS LTDImmucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides — BIOARRAY SOLUTIONS LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-15 | Luminex Corporation | Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot. |
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 docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.