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Stratus® CS Acute Care™ pBNP DilPak

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Stratus® CS Acute Care™ pBNP DilPak FDA UDI
Generic Name
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The Stratus® CS Acute Care™ NT-proBNP Dilution Pak (pBNP DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ pBNP TestPak on the Stratus® CS analyzer for the measurement of samples with elevated levels of NT-proBNP. FDA UDI
Model / Reference
10445085 FDA UDI
Description
The Stratus® CS Acute Care™ NT-proBNP Dilution Pak (pBNP DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ pBNP TestPak on the Stratus® CS analyzer for the measurement of samples with elevated levels of NT-proBNP. FDA UDI

Identifiers

Catalog Number
CPBNP-D FDA UDI
Primary DI / UDI-DI
00842768004667 FDA UDI
510(k) Number
K060548 FDA UDI
FDA Product Code
JIT FDA UDI
NBC FDA UDI
DHA FDA UDI
GMDN Term
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
862.1117 FDA UDI
862.1155 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

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, kit, fluorescent immunoassay

Stratus® CS Acute Care™ pBNP DilPak 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, kit, fluorescent immunoassay.

Cleared under the same submission

K060548 also covers:

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 1e841b18-3f85-45b2-9dc3-26e8fcef499c 37 fields · synced May 30, 2026