FDA.reportPublic FDA data

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (

Primary DI
06974849369229
Brand
Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (
Company
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Model
1 test/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
LLHReagents, Clostridium Difficile Toxin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLHReagents, Clostridium Difficile ToxinMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974849369229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974849369229069748493692296974849369229

GMDN Terms#

Term, Definition table
TermDefinition
Clostridium difficile 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 Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] 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
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
08033891322779CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINSDIESSE DIAGNOSTICA SENESE SPALLH2025-08-19
05032384519828ProSpecT™ Wash BufferOXOID LIMITEDLLH2024-07-05
05032384519903ProSpecT C. difficile Toxin A/B Microplate OXOID LIMITEDLLH2022-12-23
06974849369236Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.LLH2022-12-06
00848838027093Remel REMEL, INC.LLH2022-04-21
00848838068416Remel REMEL, INC.LLH2022-04-21
30848838027094Remel REMEL, INC.LLH2022-04-21
30848838068417Remel REMEL, INC.LLH2022-04-21
00857031002646C. DIFFICILE TOX A/B IITECHLAB, INC.LLH2021-05-07
00857031002660C. DIFF CHEK - 60TECHLAB, INC.LLH2021-05-03
00840733101786ImmunoCard Toxins A & BMERIDIAN BIOSCIENCE, INC.LLH2020-09-21
00840733101694PREMIER Toxins A and BMERIDIAN BIOSCIENCE, INC.LLH2020-09-01
00857031002066C. DIFFICILE TOXIN ANTITOXIN KITTECHLAB, INC.LLH2020-01-24
00857031002073C. DIFFICILE TOX-B TESTTECHLAB, INC.LLH2020-01-24
00857031002264C. DIFFICILE TOX-B TESTTECHLAB, INC.LLH2020-01-24
03573026229146VIDAS® C. difficile Toxin A & BBIOMERIEUX SALLH2019-11-08
00857031002431C. DIFFICILE TOX A/B IITECHLAB, INC.LLH2019-05-31
00857031002448C. DIFF CHEK - 60TECHLAB, INC.LLH2019-05-31
00857031002554C. DIFF QUIK CHEK COMPLETETECHLAB, INC.LLH2019-05-31
00857031002110C. DIFF CHEK - 60TECHLAB, INC.LLH2019-04-12
00857031002219C. DIFFICILE TOX A/B IITECHLAB, INC.LLH2019-04-12
00857031002226C. DIFF CHEK - 60TECHLAB, INC.LLH2019-04-12
00857031002103C. DIFFICILE TOX A/B IITECHLAB, INC.LLH2018-10-31
00857031002233C. DIFF CHEK - 60TECHLAB, INC.LLH2018-10-31
00857031002424C. DIFFICILE TOX A/B IITECHLAB, INC.LLH2018-09-28
00857031002042TOX A/B QUIK CHEKTECHLAB, INC.LLH2018-08-07
00857031002059C. DIFF QUIK CHEK COMPLETETECHLAB, INC.LLH2018-08-07
00857031002158C. DIFF QUIK CHEK COMPLETETECHLAB, INC.LLH2018-08-07
00857031002257TOX A/B QUIK CHEKTECHLAB, INC.LLH2018-08-07
00857031002370C. DIFF QUIK CHEK COMPLETETECHLAB, INC.LLH2018-08-07