Identity
- Trade Name
- DIGITAL DIAGNOSTICS SYSTEM FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- Computer to operate the Genius™ Review Station. FDA UDI
- Model / Reference
- ASSEMBLY, REVIEW STATION COMPUTER FDA UDI
- Description
- Computer to operate the Genius™ Review Station. FDA UDI
Identifiers
- Catalog Number
- ASY-17964 FDA UDI
- Primary DI / UDI-DI
- 15420045517585 FDA UDI
- 510(k) Number
- DEN210035 FDA UDI
- FDA Product Code
- QYV FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.3900 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: Laboratory instrument/analyser application software IVD
Digital Diagnostics System by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Laboratory instrument/analyser application software IVD.
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- ARCHITECT — Abbott Laboratories, Inc. · Class I
- RealTime — Abbott Molecular · Class II
- Alinity — Abbott · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Alinity — Abbott · Class I
Cleared under the same submission
DEN210035 also covers:
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
- DIGITAL DIAGNOSTICS SYSTEM — Hologic, Inc.
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
- Hologic, Inc.
Sources (1)
- FDA UDI 91fde9cc-61c4-47f1-98c7-7365e44e7da4 37 fields · synced May 30, 2026