FDA UDI
In Commercial Distribution
🇺🇸 United States
PNI Carcinoma MultiDetector (CK 5 & 6 Cocktail & NGFR)
DI: B502BSB0353500
·
Model: BSB-0353-50
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PNI Carcinoma MultiDetector (CK 5 & 6 Cocktail & NGFR)
- Primary DI
- B502BSB0353500
- Version / Model
- BSB-0353-50
- Catalog Number
- BSB-0353-50
- Company Name
- BIO SB, INC.
- Labeler DUNS
- 102855447
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-18
- Public Version
- 1
- Public Version Date
- 2025-03-26
- Public Version Status
- New
- Public Device Record Key
- 2f2ebdd2-533c-4949-b7f5-2dca608d357f
Device Description
The PNI Carcinoma MultiDetector HRP/AP Kit is a dual stain kit
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 | B502BSB0353500 | HIBCC |
Customer Contacts
- Phone
- +1(800)561-1145
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 500 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius