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Stratus® CS Acute Care™ ßhCG TestPak

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Stratus® CS Acute Care™ ßhCG TestPak FDA UDI
Generic Name
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin method (ßhCG) is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma. FDA UDI
Model / Reference
10445060 FDA UDI
Description
The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin method (ßhCG) is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma. FDA UDI

Identifiers

Catalog Number
CBHCG FDA UDI
Primary DI / UDI-DI
00842768004407 FDA UDI
510(k) Number
K060548 FDA UDI
FDA Product Code
DHA FDA UDI
NBC FDA UDI
JIT FDA UDI
GMDN Term
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1155 FDA UDI
862.1117 FDA UDI
862.1150 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: Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay

Stratus® CS Acute Care™ ßhCG TestPak by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human chorionic gonadotropin beta-subunit (beta-HCG) 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 31a642a6-bd74-4dce-9ed1-5e76c3829ca5 37 fields · synced May 30, 2026