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Dimension® NTP CAL

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® NTP CAL FDA UDI
Generic Name
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator FDA UDI
Device Name
LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL FDA UDI
Model / Reference
10464529 FDA UDI
Description
LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL FDA UDI

Identifiers

Catalog Number
RC623 FDA UDI
Primary DI / UDI-DI
00842768026324 FDA UDI
510(k) Number
K082680 FDA UDI
FDA Product Code
JIT FDA UDI
GMDN Term
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 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

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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, calibrator

Dimension® NTP CAL by Siemens Healthcare Diagnostics — 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, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 178cf1c3-bb22-4154-9be7-ce37e353375c 37 fields · synced May 31, 2026