AccessGUDID - DEVICE: Access Inhibin A Calibrators (15099590203054)

GUDID

Device Identifier (DI) Information

Brand Name: Access Inhibin A Calibrators
Version or Model: A36098
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A36098
Company Name: Beckman Coulter, Inc.

Primary DI Number: 15099590203054
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: The Access Inhibin A Calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric inhibin A levels in human serum and plasma (heparin and EDTA) as an aid in the diagnosis and monitoring of various hormonal reproductive disorders using the Access Immunoassay Systems.

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?
54228	Inhibin A IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of inhibin A in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIT	Calibrator, Secondary

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: 9d8a2697-2867-4ddc-be08-ff0e155298a6
Public Version Date: April 09, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016