Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Inorganic phosphate (PO43-) IVD, reagent FDA UDI
- Device Name
- Alinity c Phosphorus Reagent Kit 4000 test FDA UDI
- Model / Reference
- 08P4020 FDA UDI
- Description
- Alinity c Phosphorus Reagent Kit 4000 test FDA UDI
Identifiers
- Catalog Number
- 08P4020 FDA UDI
- Primary DI / UDI-DI
- 00380740135126 FDA UDI
- FDA Product Code
- CEO FDA UDI
- GMDN Term
- Inorganic phosphate (PO43-) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1580 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Inorganic phosphate (PO43-) IVD, reagent
Alinity by Abbott — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Inorganic phosphate (PO43-) IVD, reagent.
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- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Pointe Scientific, Inc. Phosphorus — POINTE SCIENTIFIC, INC. · Class I
- ACCENT-300 PHOSPHORUS — PZ CORMAY Spółka Akcyjna · IVD General
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- OS-PHOSPHORUS — PZ CORMAY Spółka Akcyjna · IVD General
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 54ee1502-d827-404f-968f-fdbc2fe88417 36 fields · synced Jun 6, 2026