Identity
- Trade Name
- IGRA Control Set FDA UDI
- Generic Name
- Interferon IVD, control FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- 1 FDA UDI
- 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). FDA UDI
Identifiers
- Catalog Number
- 628022 FDA UDI
- Primary DI / UDI-DI
- 04053228047988 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Interferon IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Interferon IVD, control
IGRA Control Set by QIAGEN Sciences LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Interferon IVD, control.
- IFN-Gamma Control Slides — BIO SB, INC. · Class I
- IFN-Alpha Control Slides — BIO SB, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- QIAGEN Sciences LLC
Sources (1)
- FDA UDI a038ff59-a3ba-47ad-a199-3ada4cacbb0c 35 fields · synced May 30, 2026