FDA.reportPublic FDA data

IGRA Control Set

Primary DI
04053228047988
Brand
IGRA Control Set
Company
QIAGEN SCIENCES INC.
Model
1
Catalog number
628022
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).
Published
2023-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053228047988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053228047988040532280479884053228047988

GMDN Terms#

Term, Definition table
TermDefinition
Interferon IVD, controlA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008675485
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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14053228033575QuantiFERON®-TB Gold Plus16235292019-12-18
14053228002120QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack 159704032017-01-04
14053228002137QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack - High Altitude159704052017-01-04
14053228002144QuantiFERON-TB Gold Blood Collection Tubes1T059003012017-01-04
14053228002151QuantiFERON-TB Gold Blood Collection Tubes - High Altitude1T059005052017-01-04
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04053228010777DML 300015000-000312016-12-21
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