Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Blood smearing cassette IVD FDA UDI
- Device Name
- Alinity h-series Smear Tape Cartridge FDA UDI
- Model / Reference
- 09P8301 FDA UDI
- Description
- Alinity h-series Smear Tape Cartridge FDA UDI
Identifiers
- Catalog Number
- 09P8301 FDA UDI
- Primary DI / UDI-DI
- 00380740132545 FDA UDI
- FDA Product Code
- KPA FDA UDI
- GMDN Term
- Blood smearing cassette IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3800 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
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: Blood smearing cassette IVD
Alinity by Abbott — 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
Sources (1)
- FDA UDI 8c03bf5b-6763-4bdd-9c15-73766f522618 36 fields · synced May 30, 2026