FDA.reportPublic FDA data

DBS Controls M2

Primary DI
06438147386956
Brand
DBS Controls M2
Company
Wallac Oy
Model
3255-0010
Catalog number
3255-0010
Device description
The DBS Controls M2 is intended for use as an external control material to evaluate the performance of lysosomal enzyme activity.This product has no qualitative or quantitative assigned value. This control is not intended for any specific patient population or specimen.
Published
2023-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OHQMulti-Analyte Controls Unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147386956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147386956064381473869566438147386956

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry enzyme IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-16 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540156544
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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06438147121373VICTOR2 D1420-0211420-0212019-03-19
06438147333202VICTOR EnLite1420-02201420-02202019-03-19
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06438147391998DBS Controls LysoPC3413-00103413-00102024-01-08
06438147392339LysoPC IS4417-00104417-00102024-01-08

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