FDA.reportPublic FDA data

GSP Wash Concentrate

Primary DI
06438147300051
Brand
GSP Wash Concentrate
Company
Wallac Oy
Model
4080-0010
Catalog number
4080-0010
Device description
For use with the GSP® instrument or the DELFIA® Platewash or the AutoDELFIA® automatic immunoassay system.
Published
2017-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147300051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147300051064381473000516438147300051

GMDN Terms#

Term, Definition table
TermDefinition
Buffered wash solution IVD, automated/semi-automated systemA buffered wash solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.

Storage And Handling#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438147371815Qsight 210 MD Screening System2040-00102040-00102023-03-29
06438147411672NeoLSD MSMS kit3093-004U3093-004U2025-08-15
06438147179596AutoDELFIA Neonatal hTSH kitB032-02CB032-02C2016-02-02
06438147179602AutoDELFIA Neonatal Thyroxine (T4) kitB065-01CB065-01C2016-02-02
06438147292479AutoDELFIA Neonatal 17α-OH-progesterone kitB024-01CB024-01C2018-11-16
06438147344406AutoDELFIA Inhibin A kit Level Calibrators B064-112-P2B064-112-P22018-11-21
06438147344420AutoDELFIA Inhibin A kit B064-112B064-1122017-10-10
06438147355037AutoDELFIA Unconjugated Estriol (uE3) kitB095-112B095-1122018-11-16
06438147377732Eonis SCID-SMA kit3241-001U3241-001U2022-11-30
06438147377756Eonis SCID-SMA kit3242-001U3242-001U2022-11-30
06438147121373VICTOR2 D1420-0211420-0212019-03-19
06438147333202VICTOR EnLite1420-02201420-02202019-03-19
06438147333219VICTOR EnLite1420-02301420-02302019-03-19
06438147064540Wallac Plate Shake1296-0041296-0042019-02-25
06438147009176DELFIA hCG kitA007-101A007-1012016-02-11
06438147009343AutoDELFIA hCG kitB007-112B007-1122016-02-11
06438147391998DBS Controls LysoPC3413-00103413-00102024-01-08
06438147392339LysoPC IS4417-00104417-00102024-01-08
06438147009336AutoDELFIA hCG kit B007-101B007-1012016-02-11
06438147356218NeoLSD MSMS kit3093-001U3093-001U2018-11-28

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