Duns Number:154281349
Device Description: B. burgdorferi (IgM) Marblot Strip Test System (400 Tests)
Catalog Number
40-5065M/B
Brand Name
Trinity Biotech
Version/Model Number
40-5065M/B
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
K951709
Product Code
LSR
Product Code Name
Reagent, Borrelia Serological Reagent
Public Device Record Key
f803a2a1-baab-419c-8595-6ede24a1aef6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 18, 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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |