Duns Number:067647321
Device Description: The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determinat The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.
Catalog Number
-
Brand Name
EZ-SHIGELLA One-Step Shigella species Rapid Test
Version/Model Number
1009-15
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GNB
Product Code Name
Antisera, All Types, Shigella Spp.
Public Device Record Key
561f3fec-ea61-4b45-a20a-33e084c52ff5
Public Version Date
July 09, 2020
Public Version Number
1
DI Record Publish Date
July 01, 2020
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 |