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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
ARCHITECT BNP Reagent Kit FDA UDI
Model / Reference
08K2836 FDA UDI
Description
ARCHITECT BNP Reagent Kit FDA UDI

Identifiers

Catalog Number
08K2836 FDA UDI
Primary DI / UDI-DI
00380740145286 FDA UDI
FDA Product Code
NBC FDA UDI
GMDN Term
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1117 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: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Architect by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott

Sources (1)

  • FDA UDI 0b07aeda-77ab-48d1-bb80-937fe2762828 36 fields · synced May 30, 2026