FDA.reportPublic FDA data

LIAISON PLEX® Respiratory Flex Assay Kit

Primary DI
00840487101940
Brand
LIAISON PLEX® Respiratory Flex Assay Kit
Company
LUMINEX CORPORATION
Model
20-005-322
Catalog number
20-005-322
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.
Published
2024-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QOFMulti-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233410000LIAISON PLEX Respiratory Flex AssayLuminex Corporation2024-03-01QOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487101940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487101940008404871019408404871019400840487101940

GMDN Terms#

Term, Definition table
TermDefinition
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)785-2323support@luminexcorp.com

Regulatory Flags#

DUNS number
080778937
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840487101438LIAISON PLEX Gastrointestinal Flex Assay20-005-31120-005-3112026-06-08
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge20-006-00120-006-0012019-12-05
00840487101728Hypercoagulation Panel (HC) Sample Buffer30-001-00130-001-0012019-12-05
00840487101858LIAISON PLEX Gram-Positive Blood Culture Assay20-005-30520-005-3052025-07-11
00840487101865LIAISON PLEX Yeast Blood Culture Assay Kit20-005-30620-005-3062024-10-22
00840487101841LIAISON PLEX Gram-Negative Blood Culture Assay20-005-30320-005-3032025-06-11
00840487100127MHV Control Primers 5380638062016-12-16
00840487100233MultiCode® Chlamydophila pneumoniae Primers392539252016-12-16
00840487100240MultiCode® Legionella pneumophila Primers392639262016-12-16
00840487100257MultiCode® Mycoplasma pneumoniae Primers392739272016-12-16
00840487101049MHV DNA Sample Processing Control370037002016-12-16
00840487101056MHV DNA Sample Processing Control3700-023700-022016-12-16
00840487101063MHV DNA Sample Processing Control3700-213700-212016-12-16
00840487101070MHV DNA Sample Processing Control3700-223700-222016-12-16
00840487101087MHV DNA Sample Processing Control371037102016-12-16
00840487101100MHV DNA Amplification Control369436942016-12-16
00840487101155MHV Control Primers 1380238022016-12-16
00840487101179MHV Control Primers 2380338032016-12-16
00840487101186MHV Control Primers 23803-213803-212016-12-16
00840487101193MHV Control Primers 3380438042016-12-16

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