Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Alinity i Total B-hCG Reagent Kit 1200 Tests FDA UDI
- Model / Reference
- 07P5131 FDA UDI
- Description
- Alinity i Total B-hCG Reagent Kit 1200 Tests FDA UDI
Identifiers
- Catalog Number
- 07P5131 FDA UDI
- Primary DI / UDI-DI
- 00380740160623 FDA UDI
- FDA Product Code
- DHA FDA UDI
- GMDN Term
- Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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
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: Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay
Alinity by Abbott Ireland — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay.
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- Alinity — ABBOTT IRELAND · Class II
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 Ireland
Sources (1)
- FDA UDI 7fbe93ec-fe7b-44ed-9a85-5146a53c80c7 36 fields · synced Jun 1, 2026