Identity
- Trade Name
- Vysis FDA UDI
- Generic Name
- Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe FDA UDI
- Device Name
- Vysis ALK Break Apart FISH Probe Kit FDA UDI
- Model / Reference
- 06N38-053 FDA UDI
- Description
- Vysis ALK Break Apart FISH Probe Kit FDA UDI
Identifiers
- Catalog Number
- 06N38-053 FDA UDI
- Primary DI / UDI-DI
- 00884999042773 FDA UDI
- PMA Number
- P110012 FDA UDI
- FDA Product Code
- OWE FDA UDI
- GMDN Term
- Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe
Vysis by Abbott Molecular — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe.
- Vysis — Abbott Molecular · Class III
- Vysis — Abbott Molecular · Class III
Cleared under the same submission
P110012 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA UDI e16fba05-ae4f-46ce-96cd-d927cb9efcb9 37 fields · synced Jun 8, 2026