Macro & Micro-Test Sample Release Reagent

GUDID 06974849369045

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Nucleic acid extraction/isolation kit IVD
Primary Device ID06974849369045
NIH Device Record Key9d670f56-f3e7-40c6-adc9-58241b1c3474
Commercial Distribution StatusIn Commercial Distribution
Brand NameMacro & Micro-Test Sample Release Reagent
Version Model Number50 tests/kit
Company DUNS560300737
Company NameJiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106974849369045 [Primary]

FDA Product Code

JJHClinical Sample Concentrator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-14
Device Publish Date2022-12-06

Devices Manufactured by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

06974849369380 - Macro & Micro-Test Fluorescence Immunoassay Analyzer2024-09-27
06974849369397 - Macro & Micro-Test Fluorescence Immunoassay Analyzer2024-09-27
06974849369304 - Macro & Micro-Test HCG Pregnancy Test Midstream2023-12-05
06974849369311 - Macro & Micro-Test HCG Pregnancy Test Midstream2023-12-05
06974849369328 - Macro & Micro-Test HCG Pregnancy Test Midstream2023-12-05
06974849369335 - Macro & Micro-Test HCG Pregnancy Test Midstream2023-12-05
06974849369342 - Macro & Micro-Test LH Test2023-12-05
06974849369359 - Macro & Micro-Test LH Test2023-12-05

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