Adenovirus Antigen Detection Kit (Immunochromatography)

GUDID 06974849369175

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

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Primary Device ID06974849369175
NIH Device Record Key37107d00-1965-4b4b-969e-c3050688517d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdenovirus Antigen Detection Kit (Immunochromatography)
Version Model Number20 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 Usetrue
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
GS106974849369175 [Primary]

FDA Product Code

GOBAntigens, Ha (Including Ha Control), Adenovirus 1-33

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

On-Brand Devices [Adenovirus Antigen Detection Kit (Immunochromatography)]

0697484936917520 tests/kit
069748493691681 test/kit

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