Duns Number:102855447
Device Description: Biotinylated Anti-Mouse and Anti-Rabbit immunoglobulin used as link for high sensitivity 2 Biotinylated Anti-Mouse and Anti-Rabbit immunoglobulin used as link for high sensitivity 2-step detection system designed for detection of specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method
Catalog Number
BSB 0003L
Brand Name
Mouse/Rabbit ImmunoDetector Biotin Link
Version/Model Number
Ready-to-use, 50 ml
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
NJT
Product Code Name
Immunohistochemistry Reagents And Kits
Public Device Record Key
9672a73e-572d-4010-b54b-b23a51da9296
Public Version Date
November 09, 2020
Public Version Number
1
DI Record Publish Date
October 30, 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 | 3887 |