FDA UDI
In Commercial Distribution
🇺🇸 United States
QuantiFERON-TB Gold Blood Collection Tubes - High Altitude
DI: 14053228002151
·
Model: 1
·
QIAGEN SCIENCES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- QuantiFERON-TB Gold Blood Collection Tubes - High Altitude
- Primary DI
- 14053228002151
- Version / Model
- 1
- Catalog Number
- T05900505
- Company Name
- QIAGEN SCIENCES INC.
- Labeler DUNS
- 008675485
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2017-01-04
- Public Version
- 4
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- ec1205bb-ea71-47c2-9878-c219d703f8e2
Device Description
bulk pack
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
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
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 |
|---|---|---|---|---|
| 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 | 14053228002151 | GS1 | ||||
| Unit of Use | 04053228002154 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010033 | 000 |