AccessGUDID - DEVICE: Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence Assay (04053252367588)

GUDID

Device Identifier (DI) Information

Brand Name: Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence Assay
Version or Model: 3121
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3121
Company Name: EMD Millipore Corporation

Primary DI Number: 04053252367588
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: SimulFluor® Flu A/Flu B Immunofluorescence Assay

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:	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?
48257	Multiple-genus respiratory virus antigen 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 antigens from multiple virus genera associated with respiratory disease in a clinical specimen, using an enzyme immunoassay (EIA) method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GNW	Antisera, Cf, Influenza Virus A, B, C

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K974302	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: 9c3d1120-1694-4f92-87d2-466a0370ee7c
Public Version Date: December 18, 2023
Public Version Number: 3
DI Record Publish Date: November 28, 2022