AccessGUDID - DEVICE: Access GI Monitor Calibrators (15099590231835)

GUDID

Device Identifier (DI) Information

Brand Name: Access GI Monitor Calibrators
Version or Model: 387688
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 387688
Company Name: Beckman Coulter, Inc.

Primary DI Number: 15099590231835
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: The Access GI Monitor Calibrators are intended to calibrate the Access GI Monitor assay for the quantitative determination of CA 19-9 antigen levels in human serum and plasma 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?
54573	Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 19-9 (CA19-9) in a clinical specimen, using an enzyme immunoassay (EIA) method. CA19-9 is typically used as a marker commonly associated with gastrointestinal, pancreatic, bile duct and gallbladder cancer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIT	Calibrator, Secondary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033038	000

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: 9dc061c0-c8dd-4dc0-b38f-7569a4cc5eb2
Public Version Date: July 26, 2023
Public Version Number: 5
DI Record Publish Date: September 09, 2016