AccessGUDID - DEVICE: LIAISON PLEX® Respiratory Flex Assay Kit (00840487101940)

GUDID

Device Identifier (DI) Information

Brand Name: LIAISON PLEX® Respiratory Flex Assay Kit
Version or Model: 20-005-322
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-005-322
Company Name: LUMINEX CORPORATION

Primary DI Number: 00840487101940
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080778937 *Terms of Use

Device Description: The LIAISON PLEX® Respiratory Flex (RSP Flex) Assay is a multiplexed qualitative test for the simultaneous in vitro detection and identification of multiple bacterial and viral nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infection, including SARS-CoV-2.

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:	Yes
Prescription Use (Rx):	Yes
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?
61527	Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QOF	Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233410	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0703a478-e2cf-4b99-86ab-aec6273aae34
Public Version Date: June 28, 2024
Public Version Number: 1
DI Record Publish Date: June 20, 2024