AccessGUDID - DEVICE: Beckman Coulter PK CMV-PA System (04987270227541)

GUDID

Device Identifier (DI) Information

Brand Name: Beckman Coulter PK CMV-PA System
Version or Model: 227541
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PA2300
Company Name: FUJIREBIO INC.

Primary DI Number: 04987270227541
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 710873907 *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?
49735	Cytomegalovirus (CMV) total antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to cytomegalovirus (CMV) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSZ	System, Test, Automated Blood Grouping And Antibody

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size Type = Tests per Kit; Size Unit = 2300; Unit of Measure = Tests

Device Record Status

Public Device Record Key: c00b6241-ab88-4398-9827-4b8b41549338
Public Version Date: March 11, 2024
Public Version Number: 4
DI Record Publish Date: September 16, 2016