Identity
- Trade Name
- AIX1000 Analyzer FDA UDI
- Generic Name
- Agglutination assay digital imaging reader/analyser IVD FDA UDI
- Device Name
- AIX1000 Rapid Plasma Reagin (RPR) Analyzer (refurbished) FDA UDI
- Model / Reference
- 00400R FDA UDI
- Description
- AIX1000 Rapid Plasma Reagin (RPR) Analyzer (refurbished) FDA UDI
Identifiers
- Catalog Number
- 00400R FDA UDI
- Primary DI / UDI-DI
- B35000400R0 FDA UDI
- 510(k) Number
- K150358 FDA UDI
- FDA Product Code
- GMQ FDA UDI
- GMDN Term
- Agglutination assay digital imaging reader/analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Treponema pallidum reagin antibody IVD, kit, agglutinationAgglutination assay digital imaging reader/analyser IVD
AIX1000 Analyzer by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Agglutination assay digital imaging reader/analyser IVD.
- DG Reader Net — DIAGNOSTIC GRIFOLS SA · Class II
- ORTHO — Ortho-Clinical Diagnostics · Class II
Cleared under the same submission
K150358 also covers:
- AIX1000 Performance Check Dye Kit — Gold Standard Diagnostics, LLC
- GSD RPR Microtiterplate - 5 pack sleeve — Gold Standard Diagnostics, LLC
- Microtiterplates (5) — Gold Standard Diagnostics, LLC
- RPR Non-Reactive Control — Gold Standard Diagnostics, LLC
- RPR Reactive Control — Gold Standard Diagnostics, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI ddb57926-b558-427b-a81e-7eed0262fc7c 35 fields · synced Jun 8, 2026