FDA.reportPublic FDA data

DELFIA Platewash

Primary DI
06438147064564
Brand
DELFIA Platewash
Company
Wallac Oy
Model
1296-026
Catalog number
1296-026
Device description
1296-026 DELFIA Platewash is a washer designed for automatic washing of microtitration strips or plates. It is self-contained, having built-in pumps for vacuum and dispensing and supplied with all the bottles and tubing needed for operation. For use with DELFIA analytes, ready-made programs are accessible.
Published
2021-06-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147064564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147064564064381470645646438147064564

GMDN Terms#

Term, Definition table
TermDefinition
Microplate washer IVD, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for washing microplates containing multiple individual sample wells (i.e., the removal of biological specimen residue, stains, or impurities) by dispensing and aspirating measured volumes of washing solution as part of the processing required to perform an in vitro diagnostic assay. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540156544
Device count
1
Premarket exempt
true
Serial number
true

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Primary DI, Brand, Model table
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06438147333202VICTOR EnLite1420-02201420-02202019-03-19
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06438147064540Wallac Plate Shake1296-0041296-0042019-02-25
06438147009176DELFIA hCG kitA007-101A007-1012016-02-11
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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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