LIAISON PLEX® Respiratory Flex Assay Kit 20-005-322

GUDID 00840487101940

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.

LUMINEX CORPORATION

Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00840487101940
NIH Device Record Key0703a478-e2cf-4b99-86ab-aec6273aae34
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIAISON PLEX® Respiratory Flex Assay Kit
Version Model Number20-005-322
Catalog Number20-005-322
Company DUNS080778937
Company NameLUMINEX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840487101940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QOFMulti-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-28
Device Publish Date2024-06-20

Devices Manufactured by LUMINEX CORPORATION

00840487101865 - LIAISON PLEX Yeast Blood Culture Assay Kit2024-10-30 The LIAISON PLEX® Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for
00840487101940 - LIAISON PLEX® Respiratory Flex Assay Kit2024-06-28The 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.
00840487101940 - LIAISON PLEX® Respiratory Flex Assay Kit2024-06-28 The LIAISON PLEX® Respiratory Flex (RSP Flex) Assay is a multiplexed qualitative test for the simultaneous in vitro detection a
00840487101957 - LIAISON PLEX® Chassis2024-06-28 The LIAISON PLEX® is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The
00840487101964 - LIAISON PLEX® Chassis (Refurbished)2024-06-28 The LIAISON PLEX® is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The
00840487101971 - LIAISON PLEX® Module2024-06-28 The LIAISON PLEX® Module is a component of the LIAISON PLEX® Chassis. When installed in the LIAISON PLEX® Chassis it is capa
00840487101988 - LIAISON PLEX® Module (Refurbished)2024-06-28 The LIAISON PLEX® Module is a component of the LIAISON PLEX® Chassis. When installed in the LIAISON PLEX® Chassis it is capa
00840487101797 - MAGPIX® Drive Fluid PLUS (4PK)2022-09-16 The MAGPIX Drive Fluid PLUS serves as the delivery medium that carries the sample to the optics component of the MAGPIX instrume
00840487101803 - xMAP® Sheath Fluid PLUS2022-09-16 Sheath Fluid PLUS is the delivery medium of the sample to the optics component.

Trademark Results [LIAISON PLEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIAISON PLEX
LIAISON PLEX
98062754 not registered Live/Pending
DIASORIN S.P.A.
2023-06-28
LIAISON PLEX
LIAISON PLEX
98062754 not registered Live/Pending
LUMINEX CORPORATION
2023-06-28
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