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Cryptosporidium Spp.

FDA product code MHJ · Class 2 · Microbiology

18
Registered devices
5
Adverse events
1
Recalls
15
510(k) clearances

Devices with this code

NA — OXOID LIMITEDTRI-COMBO PARASITE SCREEN — TECHLAB, INC.CRYPTOSPORIDIUM II — TECHLAB, INC.TRI-COMBO PARASITE SCREEN — TECHLAB, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.NA — REMEL, INC.CRYPTOSPORIDIUM II — TECHLAB, INC.NA — REMEL, INC.GIARDIA/CRYPTOSPORIDIUM CHEK — TECHLAB, INC.Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] — BIOMERICA, INC.Cryptosporidium Antigen (stool) ELISA — DRG International IncTrinityBiotech — MARDX DIAGNOSTICS, INC.Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay — MEDICAL CHEMICAL CORPORATIONGiardia/Cryptosporidium Ag (stool) ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungCryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] — BIOMERICA, INC.Triage® — Alere San Diego, Inc.GIARDIA/CRYPTOSPORIDIUM CHEK — TECHLAB, INC.Cryptosporidium Antigen (stool) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung

Recent 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 P

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.