AccessGUDID - DEVICE: Monobind AccuLite Free B-hCG XR CLIA Kit

GUDID

Device Identifier (DI) Information

Brand Name: Monobind AccuLite Free B-hCG XR CLIA Kit - 96 Wells
Version or Model: 10275-300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10275-300A
Company Name: MONOBIND, INC.

Primary DI Number: 00816870022253
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083155515 *Terms of Use

Device Description: No description.

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:	No
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?
54215	Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent 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 chemiluminescent immunoassay method. It is used in foetal screening of Down syndrome and other chromosomal abnormalities during pregnancy.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DHA	SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Handling Environment Temperature
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 7.75 Inch

Device Record Status

Public Device Record Key: 79f4c736-ab6e-4529-b2cc-7a1f7d7eaba4
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 11, 2019