FDA UDI
In Commercial Distribution
🇺🇸 United States
Mouse/Rabbit PolyDetector Plus DAB HRP Brown Detection Systems
DI: B502BSB02610
·
Model: 100 ml each
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mouse/Rabbit PolyDetector Plus DAB HRP Brown Detection Systems
- Primary DI
- B502BSB02610
- Version / Model
- 100 ml each
- Catalog Number
- BSB 0261
- Company Name
- BIO SB, INC.
- Labeler DUNS
- 102855447
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 1
- Public Version Date
- 2020-09-08
- Public Version Status
- New
- Public Device Record Key
- ebbf8c81-dded-4c43-b78b-8f468c98e06a
Device Description
Mouse/Rabbit PolyDetector Plus HRP/DAB System is a 2-step polymeric detection system that allows for the demonstration of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | Hematology | 864.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57771 | Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry | A collection of reagents and other associated materials intended to be used for the discrete visualisation of immune complexes bound to specific cellular markers in a clinical specimen. Sustrates are used to detect immunoperoxidase-bound complexes and may include diaminobenzidine (DAB), aminoethylcarbazole (AEC), nitro blue tetrazolium/bromochloroindolyl phosphate (NBT/BCIP) and/or fast red using an enzyme immunohistochemistry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B502BSB02610 | HIBCC |