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ANTI-PR3 (cANCA)
ORGENTEC Diagnostika GmbH · Model ORG518 · UDI-DI 04260157080171
MOB
Prescription
10
510(k) clearances
3
Adverse events (1 deaths)
1
Recalls
25
Facilities
Description
Anti-PR3 is an ELISA test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-24 | Phadia Ab | Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA w |
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