Duns Number:844766394
Device Description: Anti-Borrelia (Lyme) EIA, Positive Control
Catalog Number
25271
Brand Name
Bio-Rad Laboratories, Inc.
Version/Model Number
25271
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K911590
Product Code
LSR
Product Code Name
REAGENT, BORRELIA SEROLOGICAL REAGENT
Public Device Record Key
efdac1de-97e5-4072-8d7b-ba7f7f18486a
Public Version Date
July 29, 2021
Public Version Number
5
DI Record Publish Date
September 12, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 98 |
3 | A medical device with high risk that requires premarket approval | 30 |