FDA UDI
In Commercial Distribution
🇺🇸 United States
HER2 neu PolyDetector DAB HRP Brown Detection System
DI: B502BSB02450
·
Model: 70 tests
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HER2 neu PolyDetector DAB HRP Brown Detection System
- Primary DI
- B502BSB02450
- Version / Model
- 70 tests
- Catalog Number
- BSB 0245
- Company Name
- BIO SB, INC.
- Labeler DUNS
- 102855447
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-30
- Public Version
- 1
- Public Version Date
- 2020-10-08
- Public Version Status
- New
- Public Device Record Key
- 88bc5611-e2d8-444e-b2c8-4a8c7937ca20
Device Description
HER-2 neu PolyDetector DAB HRP Brown Detection System is a non-biotin, 1-step polymeric detection system that allows for the Immunohistochemical detection of HER-2 neu overexpression.
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 | B502BSB02450 | HIBCC |