Getein Biotech Inc

FDA Filings

This page includes the latest FDA filings for Getein Biotech Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

CHINASHANGHAI STOCK EXCHANGE603387DUNS 542973494
FDA Registration(s)
Registration Number3009984016
FEI Number3009984016
NameGETEIN BIOTECH, INC.
Owner & OperatorGetein Biotech, Inc.
Contact AddressNo.9 Bofu Road, Luhe District,
Nanjing CN-32 Jiangsu 211505 CN
Official Correspondent
  • Ling Chen
  • 86-25-6856850-8
US Agent
Importing Logistics Registration
ImporterGetein Biomedical Inc.
Address4640 SW Macadam Ave., Suite 130C Portland, OR
Portland, OR 97239 UNITED STATES
Email Addressdebra.jing@gp-diagnostics.com
Phone1 650 7935804
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNo.9 Bofu Road, Luhe District,
Nanjing Jiangsu, 211505 CN
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
GETEIN BIOTECH, INC.
Single-Use Face Mask (Non-Sterile)2020-04-15
GETEIN BIOTECH, INC.
One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)2020-03-26
GETEIN BIOTECH, INC.
Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit2020-03-26
GETEIN BIOTECH, INC.
Getein1100 Immunofluorescence Quantitative Analyzer2020-03-26

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