Stratus® CS Acute Care™ ßhCG DilPak - The Stratus® CS Acute Care™ Beta human Chorionic - Siemens Healthcare Diagnostics Inc.

Duns Number:005088112

Device Description: The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin Dilution Pak (ßhCG DilPak), The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin Dilution Pak (ßhCG DilPak), in vitro diagnostic product intended to be used in conjunction with the Acute Care™ ßhCG TestPak on the Stratus® CS analyzer for the measurement of samples with elevated ßhCG levels.

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More Product Details

Catalog Number

CBHCG-D

Brand Name

Stratus® CS Acute Care™ ßhCG DilPak

Version/Model Number

10445062

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K060548,K060548

Product Code Details

Product Code

DHA

Product Code Name

SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Device Record Status

Public Device Record Key

d25d771c-3ff0-44de-af0f-3a972f28bb8e

Public Version Date

November 19, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIEMENS HEALTHCARE DIAGNOSTICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 363
2 A medical device with a moderate to high risk that requires special controls. 829
3 A medical device with high risk that requires premarket approval 57
U Unclassified 7