The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium-specific antigen (CSA) in fecal specimens. This assay is intended for in vitro diagnostic use only.

The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium
Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] - 7063

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from species of the parasitic protozoan Cryptosporidium in a clinical specimen, using an enzyme immunoassay (EIA) method.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MHJ

Device Name: Cryptosporidium Spp.

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3220

Third Party Flag: N

Medical Specialty: MI

Device Id: 08305900070637

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A