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GSP, Genetic Screening Processor
EUDAMEDFDA UDIClass A (EU MDR)
Ref 2021-0010
by Wallac Oy
Identity
- Trade Name
- GSP, Genetic Screening Processor EUDAMEDGenetic Screening Processor FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- GSP, Genetic Screening Processor EUDAMEDThe 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. FDA UDI
- Model / Reference
- 2021-0010 EUDAMEDFDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 2021-0010 FDA UDI
- Primary DI / UDI-DI
- 06438147311040 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438147GSP_7V EUDAMED
- 510(k) Number
- K090846 FDA UDI
- FDA Product Code
- KHO FDA UDI
- EMDN Code
- W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) EUDAMED
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2560 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
GSP, Genetic Screening Processor by Wallac Oy — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6438147GSP_7V | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED 57768d52-6927-46c8-86f1-46a67481efad 61 fields · synced Jul 30, 2026
- FDA UDI 99744322-967c-48af-9d27-6d4e92e1c160 35 fields · synced May 30, 2026