FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00382906559333
·
Model: 655933
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00382906559333
- Version / Model
- 655933
- Catalog Number
- 655933
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 024230633
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-28
- Public Version
- 3
- Public Version Date
- 2022-02-11
- Public Version Status
- Update
- Public Device Record Key
- 6e184da0-02f7-4304-ba96-790931f8a664
Device Description
BD® Anti-Human IFN-g (25723.11) APC
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 |
|---|---|---|---|---|
| 60747 | Interferon gamma release IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of interferon gamma (IFN gamma) released in response to T-cell activation resulting from stimulation by one or multiple specific antigens or mitogens, including (but not limited to) B Borrelia species, Epstein-Barr virus (EBV), Cytomegalovirus (CMV), BK virus, severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), and/or Mycobacterium species. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382906559333 | GS1 |
Customer Contacts
- Phone
- +1(877)232-8995
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius