FDA.reportPublic FDA data

Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)

Primary DI
06974849369182
Brand
Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)
Company
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Model
10 tests/kit
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GOBAntigens, Ha (Including Ha Control), Adenovirus 1-33

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GOBAntigens, Ha (Including Ha Control), Adenovirus 1-33Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974849369182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974849369182069748493691826974849369182

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gastrointestinal virus 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 multiple gastrointestinal viruses, which may include adenovirus and/or rotavirus, 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
560300737
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974849369052Macro & Micro-Test Automatic Nucleic Acid ExtractorHWTS-NPure322022-12-06
06974849369403EudemonTM AIO800HWTS-AIO800HWTS-EQ0552024-11-14
06974849369076Easy Amp Real-time Fluorescence Isothermal Detection SystemHWTS-1600S2022-12-06
06974849369083Easy Amp Real-time Fluorescence Isothermal Detection SystemHWTS-1600P2022-12-06
06974849369380Macro & Micro-Test Fluorescence Immunoassay AnalyzerHWTS-IF10002024-09-19
06974849369397Macro & Micro-Test Fluorescence Immunoassay AnalyzerHWTS-IF20002024-09-19
06974849369304Macro & Micro-Test HCG Pregnancy Test Midstream1 test/kit2023-11-27
06974849369311Macro & Micro-Test HCG Pregnancy Test Midstream20 tests/kit2023-11-27
06974849369328Macro & Micro-Test HCG Pregnancy Test Midstream3 tests/kit2023-11-27
06974849369335Macro & Micro-Test HCG Pregnancy Test Midstream5 tests/kit2023-11-27
06974849369342Macro & Micro-Test LH Test1 test/kit2023-11-27
06974849369359Macro & Micro-Test LH Test3 tests/kit2023-11-27
06974849369366Macro & Micro-Test LH Test5 tests/kit2023-11-27
06974849369373Macro & Micro-Test LH Test20 tests/kit2023-11-27
06974849369007Macro & Micro-Test Viral DNA/RNA Kit50 tests/kit2022-12-06
06974849369014Macro & Micro-Test Viral DNA/RNA Kit32 tests/kit2022-12-06
06974849369021Macro & Micro-Test Viral DNA/RNA Kit48 tests/kit2022-12-06
06974849369038Macro & Micro-Test Viral DNA/RNA Kit96 tests/kit2022-12-06
06974849369045Macro & Micro-Test Sample Release Reagent50 tests/kit2022-12-06
06974849369069Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit50 tubes/kit 2mL2022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974849369168Adenovirus Antigen Detection Kit (Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GOB2022-12-06
06974849369175Adenovirus Antigen Detection Kit (Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GOB2022-12-06
06974849369199Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GOB2022-12-06