Alere NT-proBNP for Alinity Reagent Kit (200 Tests) (UDI 04S7921)
Manufactured by AXIS-SHIELD DIAGNOSTICS LIMITED
Device Regulatory Overview
The Alere NT-proBNP for Alinity Reagent Kit (200 Tests) (Model/Catalog Number: 04S7921) is a medical device manufactured by AXIS-SHIELD DIAGNOSTICS LIMITED. This product is indexed under FDA Product Code / Category Classification NBC within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 04S7921
- Product Code / EMDN
- NBC
- Device Name
- The Alere NT-proBNP for Alinity i assay is a chemiluminescent microparticle immunoassay (CMIA) used for the in vitro quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma on the Alinity i system.In the emergency department, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.
- Database Sync Date
- 2026-08-09 09:08:16
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Alere NT-proBNP for Alinity Reagent Kit (200 Tests)?
The registered manufacturer of record for Alere NT-proBNP for Alinity Reagent Kit (200 Tests) is AXIS-SHIELD DIAGNOSTICS LIMITED.
What is the Primary UDI-DI identifier for Alere NT-proBNP for Alinity Reagent Kit (200 Tests)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04S7921.
What classification code is assigned to this device?
This device is registered under product classification code NBC.
Similar Classification Devices (NBC)
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