Altruan GmbH
Massing, DE
Altruan GmbH appears in FDA device records in Massing, DE. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 3
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1561-2026 | Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs. | Product not cleared by the FDA. | Class II | Open, Classified | |
| Z-1560-2026 | Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples. | Product not cleared by the FDA. | Class II | Open, Classified | |
| Z-1559-2026 | Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection. | Product not cleared by the FDA. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain