Duns Number:067647321
Device Description: The Biomerica Salmonella test is a lateral flow immunoassay for the rapid determination of The Biomerica Salmonella test is a lateral flow immunoassay for the rapid determination of the presence of Salmonella species in human stool samples. The test is intended for professional use only.
Catalog Number
-
Brand Name
EZ-SALMONELLA One-Step Salmonella species Rapid Test
Version/Model Number
1007-15
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
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GRM
Product Code Name
Antisera, All Groups, Salmonella Spp.
Public Device Record Key
bf883c35-7387-434c-b595-b690439c6685
Public Version Date
June 10, 2022
Public Version Number
4
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 |