Identity
- Trade Name
- Alinity-Architect FDA UDI
- Generic Name
- Assay container IVD, single-use FDA UDI
- Device Name
- Transplant Pretreatment Tubes FDA UDI
- Model / Reference
- 01P0603 FDA UDI
- Description
- Transplant Pretreatment Tubes FDA UDI
Identifiers
- Catalog Number
- 01P0603 FDA UDI
- Primary DI / UDI-DI
- 00380740168209 FDA UDI
- FDA Product Code
- MLM FDA UDIMKW FDA UDINRP FDA UDI
- GMDN Term
- Assay container IVD, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1678 FDA UDI862.1235 FDA UDI862.3840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assay container IVD, single-use
Alinity-Architect by Abbott Laboratories, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI 63d10d7e-b9da-422a-a37b-11a0c80a5835 36 fields · synced May 31, 2026