Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009984016

FEI Number

3009984016

Entity Name

GETEIN BIOTECH, INC.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

No.9 Bofu Road, Luhe District,, Nanjing Jiangsu 211505, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Getein Biotech, Inc. (Owner Number: 10064252)

Owner / Operator Contact Address

No.9 Bofu Road, Luhe District,, Nanjing, CN-JS 211505, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

C-Peptide Fast Test Kit (Immunofluorescence Assay) MAGICL C- Peptide (CLIA) MAGICL Insulin (CLIA) Insulin Fast Test Kit(Immunofluorescence Assay) Thyroid function series Multi Control 1 Hormone series Multi Control 1 MAGICL Tg (CLIA) GN 7120 Akso PCR System GN 7000 Akso PCR System MAGICL FSH (CLIA) Composite Calibrator serum Lipid Compound Calibrator MAGICL PRL (CLIA) MAGICL Progesterone (CLIA) T3 Fast Test Kit (Immunofluorescence Assay) MAGICL FT3 (CLIA) MAGICL T3 (CLIA) Getein 1150 Immunofluorescence Quantitative Analyzer T4 Fast Test Kit (Immunofluorescence Assay) MAGICL hGH (CLIA) MAGICL LH (CLIA)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2026-03-12
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2026-03-12
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2026-03-20
CEE	Radioimmunoassay, Thyroxine-Binding Globulin	Clinical Chemistry	Class 2	862.1685	2023-03-09
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2026-03-12
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2023-03-09
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2023-03-09
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2023-03-09
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2023-03-09
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2023-03-09
JZT	Fluorometer	Immunology	Class 1	866.4520	2026-03-12
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2026-04-10
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2023-03-09
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2023-03-09

Official Correspondent

Harry Zhao

US Agent Details

Andy Smith. Business: GRZAN GROUP INC. Email: info@grzan-ar.com Phone: (332) 2015192

Related Public Records

Same Entity

Getein Biotech, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04
K833852	Syncor Intl. Corp.	FSH RIA	1984-01-13
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009984016. Last updated year: 2026. Please use registration number 3009984016 when referencing this establishment in official correspondence.