FDA.reportPublic FDA data

TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control

Primary DI
10190302019033
Brand
TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control
Company
LIFE TECHNOLOGIES CORPORATION
Model
963613
Device description
Component 2 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
Published
2025-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K241806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241806000Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select PanelLife Technologies Corporation2025-01-08QOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302019033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030201903310190302019033

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-genus respiratory virus 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 virus genera associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790376870
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190302018449QuantStudio™ 7 Pro Dx Software, V3.0.0A546262022-09-12
10190302018159appliedbiosystems QuantStudioTM 7 Pro Dx SoftwareA52649, V2.0.02022-05-02
10190302017862QuantStudio™ 7 Pro Dx SoftwareA52015, V1.0.52021-12-10
10190302002691Dulbecco's Phosphate Buffered Saline (D-PBS)140401412016-08-04
10190302000635Dulbecco's Phosphate Buffered Saline (D-PBS)141901362016-08-01
10190302002684Hanks' Balanced Salt Solution (HBSS)140250922016-08-04
10190302002721Dulbecco's Phosphate Buffered Saline (D-PBS)140401332016-08-04
10190302002837Hanks' Balanced Salt Solution (HBSS)141701122016-08-04
10190302002844Hanks' Balanced Salt Solution (HBSS)141750952016-08-04
10190302002875Hanks' Balanced Salt Solution (HBSS)141750792016-08-04
10190302003018Dulbecco's Phosphate Buffered Saline (D-PBS)142000752016-08-04
10190302003858Hanks' Balanced Salt Solution (HBSS)240201172016-08-04
10190302000628Dulbecco's Phosphate Buffered Saline (D-PBS)140401172016-08-01
10190302002950Dulbecco's Phosphate Buffered Saline (D-PBS)141901442016-08-01
10190302019439Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferA577402025-02-17
10190302018982TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564402025-02-17
10190302018999TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control9636122025-02-17
10190302019002TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control9636092025-02-17
10190302019019TaqPath™ 1-Step Select Master Mix (No ROX)A56518A561232025-02-17
10190302019026TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564412025-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00819704020074FINDER InstrumentBaebies, Inc.QOF2026-05-01
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00819704020463FINDER Cleaning AccessoryBaebies, Inc.QOF2026-05-01
00819704020487FINDER RVP BufferBaebies, Inc.QOF2026-05-01
00819704020630FINDER Flu A&B/SARS-CoV-2 Positive Control SwabBaebies, Inc.QOF2026-05-01
00819704020654FINDER Flu A&B/SARS-CoV-2 Negative Control SwabBaebies, Inc.QOF2026-05-01
05061098480025NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
05061098480032NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007329cobas® Respiratory flex Control KitRoche Molecular Systems, Inc.QOF2026-02-24
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20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCQOF2026-01-22
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCQOF2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCQOF2026-01-14
04053228039402QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
14053228039409QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
00884999049369Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00884999049376Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00884999049383Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00875197006285cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testRoche Molecular Systems, Inc.QOF2025-05-28
00875197007299cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testRoche Molecular Systems, Inc.QOF2025-05-28
00875197007305cobas liat SARS-CoV-2, Influenza A/B & RSV control kitRoche Molecular Systems, Inc.QOF2025-05-28
00810031720019Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19
10810031720016Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19
10190302018982TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17
10190302018999TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive ControlLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17
10190302019002TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative ControlLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17
10190302019019TaqPath™ 1-Step Select Master Mix (No ROX)LIFE TECHNOLOGIES CORPORATIONQOF2025-02-17
10190302019026TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17