Nano-Check™ COVID-19 Antigen Control Kit

Primary DI
00895160002991
Brand
Nano-Check™ COVID-19 Antigen Control Kit
Company
NANO-DITECH CORPORATION
Model
MD-8147EX
Catalog number
MD-8147EX
Device description
Nano-Check™ COVID-19 Antigen Control Kit is an external quality control kit intended for use with the Nano-Check™ COVID-19 Antigen Test. The kit contains one Positive Control Swab and one Negative Control Swab to verify the performance of the test system. The control kit is intended to support routine quality control procedures and should be used according to the instructions for use. This product is not intended for the detection of SARS-CoV-2 in patient specimens and is not for diagnostic use.
Published
2026-08-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJZKit, Direct Antigen, Positive Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJZKit, Direct Antigen, Positive ControlClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10895160002998PackageGS150In Commercial Distribution
00895160002991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089516000299810895160002998
00895160002991008951600029918951600029910895160002991

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at 2°C to 30°C

Contacts#

Phone, Email table
PhoneEmail
1-855-297-7877info@nano-ditech.com

Regulatory Flags#

DUNS number
126544316
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00895160002427Fluoro-CheckTM PCTTF3161TF31612016-10-05
00895160002878Nano-Check™ Influenza A+B TestMD81532026-01-22
10895160002875Nano-Check™ Influenza A+B TestMD81532026-01-22
00895160002960Nano-Check Influenza+COVID-19 Dual TestMD81542026-01-16
10895160002967Nano-Check Influenza+COVID-19 Dual TestMD81542026-01-16
00895160002847Nano-Check Influenza+COVID-19 Dual TestMD8151E2024-08-08
10895160002844Nano-Check Influenza+COVID-19 Dual TestMD8151E2024-08-08
00895160002854Nano-Check RSV TestMD81522024-08-08
00895160002861Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147 2T2024-04-01
10895160002868Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147 2T2024-04-01
00895160002786Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147-20T2020-11-18
00895160002243Nano-Check™ OPI TestAD41832023-06-27
10895160002240Nano-Check™ OPI TestAD41832023-06-27
00895160002663Nano-CheckTM COVID-19 IgG/IgM Antibody TestMD81452020-04-10
00895160002670Fluoro-CheckTM CRP Test TF31632020-09-22
00895160002687Nano-Check TM Strep A TestMD81482022-03-15
00895160002694Nano-Check TM CRP plus TestCD71572022-03-15
00895160002724Nano-Check TM COVID-19 IgG Antibody TestMD81462020-09-22
00895160002793Fluoro-Check TM COVID-19 Antigen TestTF-81502020-11-25
00895160002120Nano-CheckTM AMI 2 in 1CD202PCD202P2016-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816862027303WELLlife™WONDFO USA CO., LTD.MJZ2026-06-01
30014613340768QuickVue™WONDFO USA CO., LTD.MJZ2025-10-31
08809115900401QuickFinder™ COVID-19/Flu Antigen Pro Control Swab KitOSANG HEALTHCARE Co., Ltd.MJZ2025-03-12
15099590745172ACCESS HIV Ag/Ab combo QCBeckman Coulter, Inc.MJZ2024-03-15
10845357043754Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.MJZ2022-02-16
10811877010712BinaxNOW® Malaria Positive Control KitAlere Scarborough, Inc.MJZ2016-09-03