Identity
- Trade Name
- PB-MAX Karyotyping Medium EUDAMEDPB-MAX™ Karyotyping Medium FDA UDI
- Generic Name
- Cell culture medium IVD FDA UDI
- Device Name
- PB-MAX Karyotyping Medium EUDAMED
- Model / Reference
- 12557-013 EUDAMED12557013 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302002462 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190302TCF00003684U EUDAMED
- FDA Product Code
- KIQ FDA UDI
- EMDN Code
- W01030701 CHROMOSOME CULTURE KITS / REAGENTS EUDAMED
- GMDN Term
- Cell culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.2260 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
PB-MAX Karyotyping Medium by Life Technologies Corporation ( Grand Island ) — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0190302TCF00003684U | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Corporation ( Grand Island )
- EUDAMED SRN
- US-MF-000029796
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (2)
- EUDAMED 518d47e7-4076-41a3-9f66-22aa01ce69e6 61 fields · synced Jun 18, 2026
- FDA UDI aeca408d-a8dc-43b4-abee-de08e9827b39 32 fields · synced May 30, 2026