Identity
- Trade Name
- BioArray Assay Imaging System TM (AIS) 400C FDA UDI
- Generic Name
- Microarray analyser IVD, semi-automated FDA UDI
- Model / Reference
- 790-20006-RF FDA UDI
Identifiers
- Catalog Number
- 790-20006-RF FDA UDI
- Primary DI / UDI-DI
- 10888234102212 FDA UDI
- FDA Product Code
- NSU FDA UDI
- GMDN Term
- Microarray analyser IVD, semi-automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
Yes
FDA UDI
Category: Microarray analyser IVD, semi-automated
BioArray Assay Imaging System TM (AIS) 400C by Bioarray Solutions Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microarray analyser IVD, semi-automated.
Cleared under the same submission
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
- Bioarray Solutions Ltd
Sources (1)
- FDA UDI 7db432e8-6c45-4d36-a7c7-d16bf1b99460 35 fields · synced May 30, 2026