FDA UDI
In Commercial Distribution
🇺🇸 United States
Horizon
DI: 00382906672438
·
Model: 667243
·
Becton, Dickinson And Company
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Horizon
- Primary DI
- 00382906672438
- Version / Model
- 667243
- Catalog Number
- 667243
- Company Name
- Becton, Dickinson And Company
- Labeler DUNS
- 119218200
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-04
- Public Version
- 1
- Public Version Date
- 2025-02-12
- Public Version Status
- New
- Public Device Record Key
- 2c75f0f0-8a5d-495e-989d-7fe11c3163c8
Device Description
BD Horizon™ Anti-TCR-Cß1 (JOVI.1) APC-R700
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
- 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 |
|---|---|---|---|---|
| MVU | Reagents, specific, analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61760 | T-cell antigen receptor (TCR) gamma/delta chain 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 the gamma/delta chains of the T-cell antigen receptor (TCR) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382906672438 | GS1 |
Customer Contacts
- Phone
- +1(877)232-8995
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius