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GIARDIA/CRYPTOSPORIDIUM CHEK

TECHLAB, INC. · Model T5031 · UDI-DI 00857031002240

MHJ Prescription
1
510(k) clearances
5
Adverse events
1
Recalls
14
Facilities

Description

The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections.

Recalls

DateFirmReason
2002-05-09Remel, 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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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.