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Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP

Primary DI
06974849369281
Brand
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP
Company
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Model
50 tests/kit
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen TestMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974849369281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974849369281069748493692816974849369281

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group B Streptococcus 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 Group B beta-haemolytic Streptococcus bacteria in a clinical specimen, using a nucleic acid technique (NAT).

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
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
06974849369052Macro & Micro-Test Automatic Nucleic Acid ExtractorHWTS-NPure322022-12-06
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
07332940008161GeneXpert®CEPHEIDNJR2024-02-16
06974849369243Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369250Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369267Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369274Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
07332940007652Xpert®CEPHEIDNJR2022-07-29
07332940007669Xpert®CEPHEIDNJR2022-07-29
07332940007683GeneXpert®CEPHEIDNJR2022-05-03
07332940007690GeneXpert®CEPHEIDNJR2022-05-03
00840733102363Revogene GBS LBMERIDIAN BIOSCIENCE, INC.NJR2020-07-15
00628055344117Revogene® GBS LBMeridian Bioscience Canada IncNJR2019-10-21
15420045510470Panther Fusion®Hologic, Inc.NJR2019-07-30
15420045510890Panther Fusion®Hologic, Inc.NJR2019-07-30
15420045510463Panther Fusion®Hologic, Inc.NJR2019-07-30
15420045510906Panther Fusion®Hologic, Inc.NJR2019-07-30
10814278020045NeuMoDxTM GBS Test StripNeumodx Molecular, Inc.NJR2019-04-03
30014613336440SolanaDIAGNOSTIC HYBRIDS, INC.NJR2019-03-21
00840733102110Alethia™ Group B Streptococcus External Control KitMERIDIAN BIOSCIENCE, INC.NJR2019-01-08
00840733102196Alethia™ Group B StreptococcusMERIDIAN BIOSCIENCE, INC.NJR2019-01-08
20816101025644Simplexa™ GBS DirectDIASORIN MOLECULAR LLCNJR2018-11-20
20816101025651Simplexa™ GBS Positive Control PackDIASORIN MOLECULAR LLCNJR2018-11-20
30014613312024AmpliVueQUIDEL CORPORATIONNJR2018-08-30
07332940004521SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004538SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004545SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004569SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004583SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004606SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004767SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004880SmartCycler Dx SystemCEPHEIDNJR2018-07-03