Identity
- Trade Name
- CELL-DYN FDA UDI
- Generic Name
- Blood cell lysis reagent IVD FDA UDI
- Device Name
- CELL-DYN 3700 System CN-FREE HGB / WIC LYSE FDA UDI
- Model / Reference
- 03H62-01 FDA UDI
- Description
- CELL-DYN 3700 System CN-FREE HGB / WIC LYSE FDA UDI
Identifiers
- Catalog Number
- 03H6201 FDA UDI
- Primary DI / UDI-DI
- 00380740005115 FDA UDI
- FDA Product Code
- GGK FDA UDI
- GMDN Term
- Blood cell lysis reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8540 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Cell-Dyn by Abbott Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI 1672b7f5-d597-4bb5-b748-c6b34a5555be 36 fields · synced Jun 8, 2026