FDA UDI
In Commercial Distribution
🇺🇸 United States
IGRA Control Set
DI: 04053228047988
·
Model: 1
·
QIAGEN SCIENCES INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IGRA Control Set
- Primary DI
- 04053228047988
- Version / Model
- 1
- Catalog Number
- 628022
- Company Name
- QIAGEN SCIENCES INC.
- Labeler DUNS
- 008675485
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-04
- Public Version
- 1
- Public Version Date
- 2023-12-12
- Public Version Status
- New
- Public Device Record Key
- a038ff59-a3ba-47ad-a199-3ada4cacbb0c
Device Description
The IGRA Control Set contains human recombinant Interferon-gamma (IFN-g), and is intended for use as an optional, unassayed quality control material for assays detecting IFN-g. The IGRA Control Set product contains a set of four (4) lyophilized recombinant human Interferon-gamma (IFN-g) controls. The IFN-g controls are provided in four (4) vials (IGRA Control Vial 1, IGRA Control Vial 2, IGRA Control Vial 3 and IGRA Control Vial 4).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41370 | Interferon IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple types of interferon in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04053228047988 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius