Duns Number:067647321
Device Description: The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptospo 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.
Catalog Number
-
Brand Name
Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]
Version/Model Number
7063
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2020
Issuing Agency
In GS1
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"
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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
MHJ
Product Code Name
Cryptosporidium Spp.
Public Device Record Key
3e3e3412-cf8f-47ff-b8b9-780b36641461
Public Version Date
September 02, 2021
Public Version Number
3
DI Record Publish Date
December 08, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |