FDA UDI
In Commercial Distribution
🇺🇸 United States
QuantiFERON®-TB Gold Plus
DI: 14053228015892
·
Model: 1
·
QIAGEN SCIENCES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- QuantiFERON®-TB Gold Plus
- Primary DI
- 14053228015892
- Version / Model
- 1
- Catalog Number
- 622536
- Company Name
- QIAGEN SCIENCES INC.
- Labeler DUNS
- 008675485
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-10-02
- Public Version
- 5
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- ec8fb3b7-9766-4d52-b4ff-ec804317e23f
Device Description
QFT-Plus Blood Collection Tubes (50x)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| NCD | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60744 | Interferon gamma release IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be 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, using an enzyme immunoassay (EIA) method. It is typically used as an indirect marker of infection for (but not limited to) 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 | 14053228015892 | GS1 | ||||
| Unit of Use | 04053228015895 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010033 | 031 |