E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica E. histolytica/dispar ELISA is - BIOMERICA, INC.

Duns Number:067647321

Device Description: The Biomerica E. histolytica/dispar ELISA is intended for the qualitative detection of Ent The Biomerica E. histolytica/dispar ELISA is intended for the qualitative detection of Entamoeba specific antigen in fecal specimens. This assay is intended for in vitro diagnostic use only.

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More Product Details

Catalog Number

-

Brand Name

E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]

Version/Model Number

7078

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KHW

Product Code Name

Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Device Record Status

Public Device Record Key

7b263525-a8c6-4290-a1be-3133a83074f2

Public Version Date

July 09, 2020

Public Version Number

1

DI Record Publish Date

July 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 35