Identity
- Trade Name
- COLCEMID EUDAMEDColcemid Solution FDA UDI
- Generic Name
- Cell culture medium IVD FDA UDI
- Device Name
- COLCEMID Solution EUDAMEDColcemid Solution 10µg/mL in Hank’s Balanced Salts FDA UDI
- Model / Reference
- 9311-10ML EUDAMEDFDA UDI
- Description
- Colcemid Solution 10µg/mL in Hank’s Balanced Salts FDA UDI
Identifiers
- Catalog Number
- 9311 FDA UDI
- Primary DI / UDI-DI
- 00810195240408 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810195240408 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 IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.2260 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
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
Category: Cell culture medium IVD
Colcemid Solution by Irvine Scientific, Llc — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Irvine Scientific, Llc
Sources (2)
- FDA UDI c51bb0e9-03bb-49a6-9795-fdfa3c4db07f 35 fields · synced Jul 8, 2026
- EUDAMED e8de4871-2608-467b-b1d9-91b33545085e 61 fields · synced Jul 8, 2026