Duns Number:106267123
Device Description: ACCURUN 132 Borrelia burgdorferi IgM 1 x 1.0 mL
Catalog Number
2015-0081
Brand Name
ACCURUN®
Version/Model Number
2015-0081
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LSR
Product Code Name
Reagent, Borrelia Serological Reagent
Public Device Record Key
aa1bd905-67e5-4bef-b1a0-0ce85febb59a
Public Version Date
March 28, 2022
Public Version Number
3
DI Record Publish Date
September 24, 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 | 184 |
2 | A medical device with a moderate to high risk that requires special controls. | 39 |