AccessGUDID - DEVICE: AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System

GUDID

Device Identifier (DI) Information

Brand Name: AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 96 Wells
Version or Model: 8575-300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8575-300A
Company Name: MONOBIND, INC.

Primary DI Number: 00816870023281
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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
54175	Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple hormone levels in a clinical specimen using a chemiluminescent immunoassay method, 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
LOJ	KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

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
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: 94b40f3b-91a3-4d81-8b4e-6760b0321bea
Public Version Date: September 16, 2024
Public Version Number: 2
DI Record Publish Date: February 11, 2019