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CRYPTOSPORIDIUM II
TECHLAB, INC. · Model PT5014 · UDI-DI 00857031002301
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 |
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