AccessGUDID - DEVICE: CLINITEST® hCG Pregnancy Test (00630414473604)

GUDID

Device Identifier (DI) Information

Brand Name: CLINITEST® hCG Pregnancy Test
Version or Model: 10310618
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1760
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414473604
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: For in vitro diagnostics use in the detection of human chorionic gonadotropin (hCG) in urine using the Clinitek Status® analyzer(qualitative)

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?
42663	Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-) quantitative detection of human chorionic gonadotropin beta-core fragment, a metabolite of human chorionic gonadotropin beta-subunit (beta-HCG), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JHI	Visual, pregnancy hCG, prescription use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032563	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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e64beb9c-7183-4d76-8bcd-070662837ec4
Public Version Date: August 30, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016