AccessGUDID - DEVICE: Light Diagnostics ™ Coxsackievirus B Blend Monoclonal Antibodies (04053252734557)

GUDID

Device Identifier (DI) Information

Brand Name: Light Diagnostics ™ Coxsackievirus B Blend Monoclonal Antibodies
Version or Model: 3303
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3303
Company Name: EMD Millipore Corporation

Primary DI Number: 04053252734557
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 829517072 *Terms of Use

Device Description: Coxsackievirus B Blend Monoclonal Antibodies

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):	No
Over the Counter (OTC):	No
Kit:	No
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?
48561	Coxsackie A/B virus antigen 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 multiple Coxsackie virus antigens from group A and B in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GNM	Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K940471	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3220eb85-d562-443a-8429-5d81735c4d21
Public Version Date: August 25, 2023
Public Version Number: 2
DI Record Publish Date: November 29, 2022