Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- Alinity h-series May-Grunwald-Giemsa Stain FDA UDI
- Model / Reference
- 08P8101 FDA UDI
- Description
- Alinity h-series May-Grunwald-Giemsa Stain FDA UDI
Identifiers
- Catalog Number
- 08P8101 FDA UDI
- Primary DI / UDI-DI
- 00380740129606 FDA UDI
- FDA Product Code
- GJL FDA UDI
- GMDN Term
- Biological stain IVD 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: Biological stain IVD
Alinity by Abbott — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- REMEL — REMEL, INC. · Class I
- REMEL — REMEL, 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
Sources (1)
- FDA UDI 2443c33b-9e08-4dbe-8fb0-62e22a6292ca 36 fields · synced Jun 8, 2026