FDA UDI
In Commercial Distribution
🇺🇸 United States
Tinto CD142/TF/Coagulation Factor III (BSB-143)
DI: B502BSB371870
·
Model: BSB-3718-7
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tinto CD142/TF/Coagulation Factor III (BSB-143)
- Primary DI
- B502BSB371870
- Version / Model
- BSB-3718-7
- Catalog Number
- BSB-3718-7
- 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
- 75fb41e9-b47d-4f5f-a6e6-558abc748e8b
Device Description
Tinto CD142/TF/Coagulation Factor III is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 67193 | Tissue factor (TF) IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of tissue factor (TF), also known as coagulation factor III, thromboplastin or CD142, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B502BSB371870 | HIBCC |
Customer Contacts
- Phone
- +1(800)561-1145
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 7 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius