AccessGUDID - DEVICE: Access AFP Sample Diluent (H628332161)

GUDID

Device Identifier (DI) Information

Brand Name: Access AFP Sample Diluent
Version or Model: 33216
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 33216
Company Name: Beckman Coulter, Inc.

Primary DI Number: H628332161
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: The Access AFP Sample Diluent is intended for use with the Access AFP assay to dilute patient samples containing AFP concentrations greater than the S6 calibrator.

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):	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
LOK	Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Premarket Submission

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

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dc3d5f0f-be24-4611-a363-87fcf6ec55c1
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2014