DEVICE: Genetic Screening Processor (06438147311040)
Device Identifier (DI) Information
Genetic Screening Processor
2021-0010
In Commercial Distribution
2021-0010
Wallac Oy
2021-0010
In Commercial Distribution
2021-0010
Wallac Oy
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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56705 | Fluorescent immunoassay analyser IVD, laboratory |
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software.
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FDA Product Code
[?]Product Code | Product Code Name |
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KHO | Fluorometer, For Clinical Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K090846 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
99744322-967c-48af-9d27-6d4e92e1c160
September 16, 2022
4
June 30, 2016
September 16, 2022
4
June 30, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined