AccessGUDID - DEVICE: Stratus® CS Acute Care™ ßhCG TestPak (00842768004407)

GUDID

Device Identifier (DI) Information

Brand Name: Stratus® CS Acute Care™ ßhCG TestPak
Version or Model: 10445060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CBHCG
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768004407
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58789	Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen using a fluorescent immunoassay method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DHA	SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
NBC	TEST,NATRIURETIC PEPTIDE
JIT	CALIBRATOR, SECONDARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060548	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31a642a6-bd74-4dce-9ed1-5e76c3829ca5
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016