Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Reticulocyte count IVD, kit, cell count FDA UDI
- Device Name
- Alinity h-series Retic reagent FDA UDI
- Model / Reference
- 07P8004 FDA UDI
- Description
- Alinity h-series Retic reagent FDA UDI
Identifiers
- Catalog Number
- 07P8004 FDA UDI
- Primary DI / UDI-DI
- 00380740137007 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Reticulocyte count IVD, kit, cell count
Alinity by Abbott Ireland Diagnostics — 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
- Abbott Ireland Diagnostics
Sources (1)
- FDA UDI 7039e8bf-f849-470e-bdb3-c6e0b11bb26f 36 fields · synced May 30, 2026