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Prime Screen

WONDFO USA CO., LTD. · Model DSODOA-116-COT-P · UDI-DI 00816862026191

MRS
3
510(k) clearances
2
Adverse events
1
Recalls
33
Facilities

Description

1-Panel T-Swab; COT 30ng/ml

Recalls

DateFirmReason
2020-01-21Polymer Technology Systems, Inc.The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.