Identity
- Trade Name
- Procleix Auto Detect Reagents EUDAMEDProcleix Panther Lower Bay Fluids FDA UDI
- Generic Name
- Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD FDA UDI
- Device Name
- Procleix Auto Detect Reagents EUDAMEDA collection of reagents and other associated materials intended to be used to optimize an assay performed using a nucleic acid technique (NAT) on a clinical specimen. FDA UDI
- Model / Reference
- 303345 EUDAMEDProcleix Auto Detect Kit FDA UDI
- Description
- A collection of reagents and other associated materials intended to be used to optimize an assay performed using a nucleic acid technique (NAT) on a clinical specimen. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859882007627 EUDAMEDFDA UDI
- Basic UDI-DI
- 0859882007Procleix012ZF EUDAMED
- Direct Marketing DI
- 00859882007627 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 Auto Detect Reagents 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 | 0859882007Procleix012ZF | 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 26c3829d-c264-4125-83b0-c3a97295591d 61 fields · synced Jun 17, 2026
- FDA UDI e040c741-8a5f-4c20-a8c7-9e57c9adb4e7 33 fields · synced May 30, 2026