Identity
- Trade Name
- CHANG Marrow FDA UDI
- Generic Name
- Cell culture medium IVD FDA UDI
- Device Name
- Bone Marrow Culture Medium with Gentamicin. 100mL bottle. FDA UDI
- Model / Reference
- 91031-100ML FDA UDI
- Description
- Bone Marrow Culture Medium with Gentamicin. 100mL bottle. FDA UDI
Identifiers
- Catalog Number
- 91031 FDA UDI
- Primary DI / UDI-DI
- 00810195240569 FDA UDI
- FDA Product Code
- KIT FDA UDI
- GMDN Term
- Cell culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.2220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
CHANG Marrow by Irvine Scientific, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Irvine Scientific, Llc
Sources (1)
- FDA UDI 5f693da0-d112-44eb-8e22-9e6ad60d22d5 35 fields · synced May 30, 2026