Immunofluorescence Reader

GUDID 06974849369298

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

Fluorescent immunoassay analyser IVD, laboratory
Primary Device ID06974849369298
NIH Device Record Key5ccb17f6-3fed-4be4-b339-b8f292b0f4ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunofluorescence Reader
Version Model NumberHWTS IF 100
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
GS106974849369298 [Primary]

FDA Product Code

KHOFluorometer, For Clinical Use

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.

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06974849369342 - Macro & Micro-Test LH Test2023-12-05
06974849369359 - Macro & Micro-Test LH Test2023-12-05

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