Identity
- Trade Name
- Ikaros FDA UDI
- Generic Name
- Karyotyping cell-image analyser IVD FDA UDI
- Model / Reference
- Karyotyping System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250406400003 FDA UDI
- 510(k) Number
- K940240 FDA UDI
- FDA Product Code
- LNJ FDA UDI
- GMDN Term
- Karyotyping cell-image analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5260 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
No
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: Karyotyping cell-image analyser IVD
Ikaros by MetaSystems Hard & Software GmbH — 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
- MetaSystems Hard & Software GmbH
Sources (1)
- FDA UDI 0274cfb4-0dc7-4825-a4ff-047a2ed14a18 33 fields · synced Jun 9, 2026