Identity
- Trade Name
- ISOFLOW SHEATH FLUID FDA UDI
- Generic Name
- Full blood count IVD, reagent FDA UDI
- Device Name
- IsoFlow Sheath Fluid FDA UDI
- Model / Reference
- 8547008 FDA UDI
- Description
- IsoFlow Sheath Fluid FDA UDI
Identifiers
- Catalog Number
- 8547008 FDA UDI
- Primary DI / UDI-DI
- 15099590542313 FDA UDI
- FDA Product Code
- GIF FDA UDI
- GMDN Term
- Full blood count IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8200 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
Yes
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: Full blood count IVD, reagent
Isoflow Sheath Fluid by Beckman Coulter, Inc. — 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
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 97d65cb7-df8f-4e9e-95fe-d9a093df46b7 35 fields · synced Jun 8, 2026