Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer

Primary DI
80190302019438
Brand
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer
Company
LIFE TECHNOLOGIES CORPORATION
Model
A57740
Device description
Part 3 of 3 of TaqPath™ COVID-19 Diagnostic PCR Kit REF A58505
Published
2025-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 TestMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233453000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233453000Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitLife Technologies Corporation2024-07-10QQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302019439PrimaryGS10
80190302019438Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030201943910190302019439
8019030201943880190302019438

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790376870
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
Primary DIBrandCompanyProduct codePublished
20816101027136Simplexa COVID-19 Positive Control GEN II Pack DIASORIN MOLECULAR LLCQQX2025-09-17
15420045516991Aptima®Hologic, Inc.QQX2025-03-14
15420045517004Aptima®Hologic, Inc.QQX2025-03-14
15420045517035Aptima®Hologic, Inc.QQX2025-03-14
10190302019439Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
10190302019422Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay KitLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
10190302019446Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR ControlLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
07332940008581GeneXpert®CEPHEIDQQX2024-01-22
00382904453619BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYQQX2023-12-09
00382904453732BD Respiratory Viral Panel for BD MAX™ SystemBECTON, DICKINSON AND COMPANYQQX2023-09-28
00875197006841cobas® SARS-CoV-2 Qualitative 192TRoche Molecular Systems, Inc.QQX2023-09-12
00875197006858cobas® SARS-CoV-2 Qualitative Control KitRoche Molecular Systems, Inc.QQX2023-09-12
00875197006933cobas® SARS-CoV-2 Qualitative 480TRoche Molecular Systems, Inc.QQX2023-09-12
20816101027020Simplexa COVID-19 DirectDIASORIN MOLECULAR LLCQQX2023-06-16
20816101027037Simplexa COVID-19 Positive Control PackDIASORIN MOLECULAR LLCQQX2023-06-16
00851458005228BioFire® COVID-19 Test 2BIOFIRE DEFENSE, LLCQQX2023-02-16
00851458005235BioFire® COVID-19 Test 2BIOFIRE DEFENSE, LLCQQX2023-02-16
06973342000530COVID-19 Coronavirus Real Time PCR KitJiangsu Bioperfectus Technologies Co., Ltd.QQX2023-02-02
06973342000158COVID-19 Coronavirus Real Time PCR KitJiangsu Bioperfectus Technologies Co., Ltd.QQX2023-01-30
10789594001002MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001088MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001095MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001101MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001354MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001361MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001378MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16