FDA.reportPublic FDA data

DBS Controls LysoPC

Primary DI
06438147391998
Brand
DBS Controls LysoPC
Company
Wallac Oy
Model
3413-0010
Catalog number
3413-0010
Device description
The DBS Controls LysoPC is intended for use as an external control material to estimate the precision of lysophospatidylcholines C24:0-LysoPC and C26:0-LysoPC measurement in laboratory procedures.This product has no qualitative or quantitative assigned value. This control is not intended for any specific patient population or specimen.
Published
2024-01-08
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
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
06438147391998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147391998064381473919986438147391998

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

Regulatory Flags#

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

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