Identity
- Trade Name
- Acucy System FDA UDI
- Generic Name
- Photometric/spectroscopic immunoassay analyser IVD FDA UDI
- Model / Reference
- 1039 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00742860100338 FDA UDI
- FDA Product Code
- PSZ FDA UDI
- GMDN Term
- Photometric/spectroscopic immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3328 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Acucy System by Sekisui Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Sekisui Diagnostics, LLC
Sources (1)
- FDA UDI 87305a6f-26b9-4e80-a161-d64e40b2d6bf 33 fields · synced Jun 9, 2026