Identity
- Trade Name
- StemComp Reagent FDA UDI
- Generic Name
- Fixative, Orth's solution FDA UDI
- Device Name
- StemComp Reagent FDA UDI
- Model / Reference
- IM3631 FDA UDI
- Description
- StemComp Reagent FDA UDI
Identifiers
- Catalog Number
- IM3631 FDA UDI
- Primary DI / UDI-DI
- 15099590220013 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- GMDN Term
- Fixative, Orth's solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5220 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fixative, Orth's solution
StemComp Reagent by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixative, Orth's solution.
- StemTrol Control Cells — Beckman Coulter, Inc. · Class II
Cleared under the same submission
BK010044 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 II | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI e7fa5d90-9d07-4b5c-beca-ef50e260afcc 35 fields · synced Jun 8, 2026