FDA.reportPublic FDA data

Genetic Screening Processor

Primary DI
06438147311040
Brand
Genetic Screening Processor
Company
Wallac Oy
Model
2021-0010
Catalog number
2021-0010
Device description
The GSP® instrument is a fully automated, high throughput batch analyzer for time-resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The GSP instrument and GSP chemistries are for professional use only.
Published
2016-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KHOFluorometer, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHOFluorometer, For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090846000GSP INSTRUMENT AND GSP NEONATAL HTSH KITPerkinelmer, Inc.2009-09-03JLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147311040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147311040064381473110406438147311040

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540156544
Device count
1
Serial number
true

Other Devices From This Company#

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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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974849369397Macro & Micro-Test Fluorescence Immunoassay AnalyzerJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2024-09-19
08809317541259FREND SystemNanoEnTek, Inc.KHO2024-06-30
08800066300104ASFA® SCANNERMBD CO., Ltd.KHO2023-11-21
06974521002246Superbio Immunofluorescence AnalyzerShenzhen Superbio Technology Co., Ltd.KHO2023-03-22
06974521006626Bioeasy Immunofluorescence AnalyzerShenzhen Superbio Technology Co., Ltd.KHO2023-03-22
00817302022339Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYANCAROLINA LIQUID CHEMISTRIES CORPORATIONKHO2023-03-10
06974849369298Immunofluorescence ReaderJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2022-12-06
06438147335008AutoDELFIA Automatic Immunoassay SystemWallac OyKHO2022-08-11
06438147335022AutoDELFIA Automatic Immunoassay SystemWallac OyKHO2022-08-11
09120052070521INFINITE 200 PROTecan Austria GmbHKHO2021-06-22
04897078440045ALiA FIA AnalyserSANWA BIOTECH LIMITEDKHO2021-01-27
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30014613336341SofiaQUIDEL CORPORATIONKHO2020-10-21
30014613336648SofiaQUIDEL CORPORATIONKHO2020-10-21
10758750000272VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHO2020-07-31
10758750001040VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHO2020-07-31
10758750011308VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHO2020-07-31
06970136030100NAGuangzhou Labsim Biotech Co., LtdKHO2020-05-20
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