Identity
- Trade Name
- AIX1000 Analyzer EUDAMEDFDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
- Device Name
- AIX1000 Analyzer EUDAMEDAIX1000 Rapid Plasma Reagin (RPR) Analyzer FDA UDI
- Model / Reference
- 00400 EUDAMEDFDA UDI
- Description
- AIX1000 Rapid Plasma Reagin (RPR) Analyzer FDA UDI
Identifiers
- Primary DI / UDI-DI
- B350004000 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B350004000 EUDAMED
- 510(k) Number
- K150358 FDA UDI
- FDA Product Code
- GMQ FDA UDI
- EMDN Code
- W0204 INFECTIOUS IMMUNOLOGY INSTRUMENTS EUDAMED
- GMDN Term
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3820 FDA UDI
- Market of Registration
- Germany 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
Prescription Use
Yes
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
AIX1000 Analyzer by Gold Standard Diagnostics, LLC — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-B350004000 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
- EUDAMED SRN
- US-MF-000027142
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED b5ceb132-b468-47e4-8bf6-662923f577cc 61 fields · synced Aug 2, 2026
- FDA UDI 8dc581b9-91f9-484d-9731-e4bdc3ab8a8e 34 fields · synced May 30, 2026