AccessGUDID - DEVICE: Monobind Qsure Maternal Control Set (00816870020204)

GUDID

Device Identifier (DI) Information

Brand Name: Monobind Qsure Maternal Control Set
Version or Model: MC-300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MC-300
Company Name: MONOBIND, INC.

Primary DI Number: 00816870020204
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?
54178	Trisomy 21-risk hormone IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple hormone levels in a clinical specimen, in order to predict the risk of trisomy 21 (Down syndrome) as part of a first or second trimester screening assessment. Hormones assayed may include alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), pregnancy associated plasma protein A (PAPP-A), estriol and/or inhibin A.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-analyte controls, all kinds (assayed)

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: 2 Inch

Device Record Status

Public Device Record Key: 60d2c160-7d18-4d4a-b437-fc91c50705f1
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 11, 2019