FDA.reportPublic FDA data

CorDx Tyfast

Primary DI
10850042559656
Brand
CorDx Tyfast
Company
CORETESTS, INC.
Model
ACT21001-10
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
OTC
false
Sterile
false
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
10850042559656PackageGS148In Commercial Distribution
00850042559659PrimaryGS10
00850042559512Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004255965610850042559656
00850042559659008500425596598500425596590850042559659
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
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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