FDA.reportPublic FDA data

CorDx Tyfast

Primary DI
00850042559635
Brand
CorDx Tyfast
Company
CORETESTS, INC.
Model
ACT21001-25
Device description
CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
Published
2024-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QMNCovid-19 Multi-Analyte Antigen Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMNCovid-19 Multi-Analyte Antigen DeviceUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850042559632PackageGS120In Commercial Distribution
00850042559635PrimaryGS10
00850042559512Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004255963210850042559632
00850042559635008500425596358500425596350850042559635
00850042559512008500425595128500425595120850042559512

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test 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
036440919
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042559765CorDx TyfastACT21012-32025-03-07
00850042559772CorDx Tyfast ACT21013 2025-03-07
00850042559826CorDx Tyfast ACT21006-72025-03-07
00850042559833CorDx Tyfast ACT21006-212025-03-07
10850042559762CorDx TyfastACT21012-32025-03-07
10850042559779CorDx Tyfast ACT21013 2025-03-07
00850042559819CorDx TyfastACT21006-32025-03-07
10850042559823CorDx Tyfast ACT21006-72025-03-07
10850042559830CorDx Tyfast ACT21006-212025-03-07
00850042559871CorDx Tyfast ACT21011-72025-03-07
00850042559888CorDx TyfastACT21014-212025-03-07
00850042559000ACCU NEWS Pregnancy Test MidstreamMidstream2022-08-31
00850042559017ACCU NEWS Ovulation Test + Pregnancy Test Combostrip2022-08-31
00850042559536CorDx TyfastACT21002-52024-06-13
00850042559550CorDx TyfastACT21002-22024-06-13
00850042559567CorDx TyfastACT21002-42024-06-13
00850042559529CorDx TyfastACT21002-12024-06-13
00850042559666CorDx TyfastACT21003-2A2024-09-05
00850042559925CorDx TyfastACT21003-52024-09-05
00850042559932CorDx TyfastACT21003-82024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044118656iHealthiHealth Labs Inc.QMN2026-05-15
00816862026863WELLlife™ WONDFO USA CO., LTD.QMN2025-05-16
10816862026860WELLlife™ WONDFO USA CO., LTD.QMN2025-05-16
00816862026153WELLlife™WONDFO USA CO., LTD.QMN2024-12-24
10816862026150WELLlife™WONDFO USA CO., LTD.QMN2024-12-24
00816862024586WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024630WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024661WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024685WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024708WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024722WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024583WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024637WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024668WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024682WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024705WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024729WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024500WELLlife™ WONDFO USA CO., LTD.QMN2024-09-24
10816862024507WELLlife™ WONDFO USA CO., LTD.QMN2024-09-24
30810107290041Flowflex Plus COVID-19 and Flu A/B Home TestACON LABORATORIES, INC.QMN2024-08-14
00850042559536CorDx TyfastCORETESTS, INC.QMN2024-06-13
00850042559550CorDx TyfastCORETESTS, INC.QMN2024-06-13
00850042559567CorDx TyfastCORETESTS, INC.QMN2024-06-13
00850042559529CorDx TyfastCORETESTS, INC.QMN2024-06-13
10850042559533CorDx TyfastCORETESTS, INC.QMN2024-06-13
10850042559557CorDx TyfastCORETESTS, INC.QMN2024-06-13
10850042559564CorDx TyfastCORETESTS, INC.QMN2024-06-13
00850044118427iHealthiHealth Labs Inc.QMN2024-05-25
00850044118434iHealthiHealth Labs Inc.QMN2024-05-24
00850044118458iHealthiHealth Labs Inc.QMN2024-05-24