Identity
- Trade Name
- CELL-DYN FDA UDI
- Generic Name
- Reticulocyte count IVD, kit, cell count FDA UDI
- Device Name
- CELL-DYN Sapphire System RETICULOCYTE REAGENT FDA UDI
- Model / Reference
- 01H76-01 FDA UDI
- Description
- CELL-DYN Sapphire System RETICULOCYTE REAGENT FDA UDI
Identifiers
- Catalog Number
- 01H7601 FDA UDI
- Primary DI / UDI-DI
- 00380740001124 FDA UDI
- FDA Product Code
- GJH FDA UDI
- GMDN Term
- Reticulocyte count IVD, kit, cell count FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Commercial Distribution
- 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
Category: Reticulocyte count IVD, kit, cell count
Cell-Dyn by Abbott Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Reticulocyte count IVD, kit, cell count.
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- RET-SEARCH II — Sysmex Corp. · Class I
- CELL-DYN — Abbott Laboratories, Inc. · Class I
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 addad621-98a8-408c-9ae0-6ec35a6535f8 36 fields · synced Jun 1, 2026