Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Trypanosoma cruzi total antibody IVD, calibrator FDA UDI
- Device Name
- Alinity s Chagas Calibrator Kit FDA UDI
- Model / Reference
- 06P0803 FDA UDI
- Description
- Alinity s Chagas Calibrator Kit FDA UDI
Identifiers
- Catalog Number
- 06P0803 FDA UDI
- Primary DI / UDI-DI
- 00380740162979 FDA UDI
- GMDN Term
- Trypanosoma cruzi total antibody IVD, calibrator FDA UDI
Classification
- 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
No
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: Trypanosoma cruzi total antibody IVD, calibrator
Alinity by Abbott — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Trypanosoma cruzi total antibody IVD, calibrator.
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Abbott
Sources (1)
- FDA UDI 3af19db2-ede6-4cff-9ddd-dedf075033fd 36 fields · synced May 31, 2026