Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]

GUDID 00083059070637

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.

BIOMERICA, INC.

Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00083059070637
NIH Device Record Keyd608cd4e-c407-4a9a-bd74-2121e4d1f189
Commercial Distribution StatusIn Commercial Distribution
Brand NameCryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]
Version Model Number7063
Company DUNS067647321
Company NameBIOMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100083059070637 [Primary]

FDA Product Code

MHJCryptosporidium Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-09
Device Publish Date2020-07-01

On-Brand Devices [Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]]

00083059070637The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium
08305900070637The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium

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