Identity
- Trade Name
- Procleix SysCheck EUDAMEDFDA UDI
- Generic Name
- Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD FDA UDI
- Device Name
- Procleix SysCheck EUDAMEDA collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen. It may also include reference material to optimize and verify performance of the luminometer instrument. FDA UDI
- Model / Reference
- 301046E EUDAMEDInstrument Verification Solution FDA UDI
- Description
- A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen. It may also include reference material to optimize and verify performance of the luminometer instrument. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859882007405 EUDAMEDFDA UDI
- Basic UDI-DI
- 0859882007Procleix013ZH EUDAMED
- Direct Marketing DI
- 00859882007405 EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
- GMDN Term
- Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Procleix SysCheck by Grifols Diagnostic Solutions Inc. — 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 | 0859882007Procleix013ZH | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Grifols Diagnostic Solutions Inc.
- EUDAMED SRN
- US-MF-000004304
- Authorised Representative
- Diagnostic Grifols, S.A. ES-AR-000001573
Sources (2)
- EUDAMED 5c6ba2cd-ff0b-4a27-bd50-e9b397b6f14c 61 fields · synced Jul 29, 2026
- FDA UDI f6360d07-4df8-403c-962d-4f5f5c5a2177 33 fields · synced May 30, 2026