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Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]

FDA UDI

Class II (US FDA UDI)

by Biomerica, Inc.

Identity

Trade Name
Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] FDA UDI
Generic Name
Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
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. FDA UDI
Model / Reference
7063 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00083059070637 FDA UDI
FDA Product Code
MHJ FDA UDI
GMDN Term
Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA)

Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] by Biomerica, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerica, Inc.

Sources (1)

  • FDA UDI d608cd4e-c407-4a9a-bd74-2121e4d1f189 34 fields · synced May 30, 2026