Home › TECHLAB, INC. › CRYPTOSPORIDIUM II
CRYPTOSPORIDIUM II
TECHLAB, INC. · Model 30406 · UDI-DI 00857031002035
MHJ
Prescription
1
510(k) clearances
5
Adverse events
1
Recalls
14
Facilities
Description
The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2002-05-09 | Remel, Inc. | A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may |
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.