Duns Number:075150847
Device Description: The Leptospira IgG ELISA test is an enzyme immunoassay for the detection of antibodies to The Leptospira IgG ELISA test is an enzyme immunoassay for the detection of antibodies to Leptospira biflexa (serovar patoc 1) for the serological confirmation of infections in serum and plasma.
Catalog Number
EIA-4245
Brand Name
Leptopspira IgG ELISA
Version/Model Number
EIA-4245
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GRY
Product Code Name
ANTIGENS, ALL, LEPTOSPIRA SPP.
Public Device Record Key
5eec9cbe-61fe-4c3c-8b1b-72a5a4e2d457
Public Version Date
March 30, 2020
Public Version Number
2
DI Record Publish Date
June 05, 2019
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |