AccessGUDID - DEVICE: Light Diagnostics™ Respiratory Panel Viral Screening and Identification IFA Kit (08436037122651)

GUDID

Device Identifier (DI) Information

Brand Name: Light Diagnostics™ Respiratory Panel Viral Screening and Identification IFA Kit
Version or Model: 3105
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3105
Company Name: EMD Millipore Corporation

Primary DI Number: 08436037122651
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: Respiratory Panel Viral Screening and Identification IFA Kit

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?
48243	Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay	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 diseases in a clinical specimen, using a fluorescent immunoassay 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
GNY	Antisera, Fluorescent, Adenovirus 1-33

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K922801	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: 6bcc5edb-4665-4bc5-9783-570521b889d9
Public Version Date: December 18, 2023
Public Version Number: 3
DI Record Publish Date: November 28, 2022