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Stratus® CS Acute Care™ ßhCG CalPak

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Stratus® CS Acute Care™ ßhCG CalPak FDA UDI
Generic Name
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The Status® CS Acute Care(TM) Beta human Chorionic Gonadotropin CalPak calibrator (ßhCG CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care(TM) ßhCG method. FDA UDI
Model / Reference
10445061 FDA UDI
Description
The Status® CS Acute Care(TM) Beta human Chorionic Gonadotropin CalPak calibrator (ßhCG CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care(TM) ßhCG method. FDA UDI

Identifiers

Catalog Number
CBHCG-C FDA UDI
Primary DI / UDI-DI
00842768004414 FDA UDI
510(k) Number
K060548 FDA UDI
FDA Product Code
NBC FDA UDI
JIT FDA UDI
DHA 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
862.1117 FDA UDI
862.1150 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: Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay

Stratus® CS Acute Care™ ßhCG CalPak 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 83cf552f-4a83-48b5-b3ad-26dd1bb9dfcb 37 fields · synced Jun 6, 2026