Identity
- Trade Name
- Aperio AT2 DX Scanner FDA UDI
- Generic Name
- Multi-modality clinical specimen analysis system IVD FDA UDI
- Device Name
- Aperio AT2 DX Scanner for Primary Diagnosis. Includes installation and one day of training. One year warranty. Must be used in conjunction with Aperio DX Viewing Station for Primary Diagnosis. FDA UDI
- Model / Reference
- 23AT2DX FDA UDI
- Description
- Aperio AT2 DX Scanner for Primary Diagnosis. Includes installation and one day of training. One year warranty. Must be used in conjunction with Aperio DX Viewing Station for Primary Diagnosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815477020259 FDA UDI
- 510(k) Number
- K190332 FDA UDI
- FDA Product Code
- PSY FDA UDI
- GMDN Term
- Multi-modality clinical specimen analysis system IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.3700 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: Multi-modality clinical specimen analysis system IVD
Aperio AT2 DX Scanner by Leica Biosystems Imaging, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Leica Biosystems Imaging, Inc.
Sources (1)
- FDA UDI f254dbb2-1408-4001-a4f5-ac020c65b47e 37 fields · synced Jun 1, 2026