SHANGHAI MEDCONN BIOTECHNOLOGY CO., LTD.

FDA Device Registration & Listing · Jinshan District Shanghai, CN · Registration 3043654757

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3043654757
FEI Number
3043654757
Entity Name
SHANGHAI MEDCONN BIOTECHNOLOGY CO., LTD.
City/State/Country
Jinshan District Shanghai, CN
Establishment Address
No. 1018 Weichang Road, Shanyang Town,, Jinshan District Shanghai 201508, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shanghai Medconn Biotechnology Co., Ltd. (Owner Number: 10095004)
Owner / Operator Contact Address
No. 1018 Weichang Road, Shanyang Town,Jinshan District, Shanghai, CN-SH 201508, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Medconn HbA1c Assay Kit(HPLC) Medconn HbA1c Column Kit(HPLC) Medconn HbA1c Haemolyser Medconn Hemoglobin A1c Calibrator Medconn Hemoglobin A1c Control Medconn HbA1c Haemolyser Medconn 8K HbA1c Assay Kit(HPLC) Medconn Hemoglobin A1c Calibrator Medconn 8K HbA1c Column Kit(HPLC) Medconn Hemoglobin A1c Control

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2026-01-14
PDJ Hemoglobin A1c Test System Clinical Chemistry Class 2 862.1373 2026-01-14
PDJ Hemoglobin A1c Test System Clinical Chemistry Class 2 862.1373 2026-01-14
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2026-01-14

Official Correspondent

Guan Judan

US Agent Details

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

Related Public Records

Same Entity

Shanghai Medconn Biotechnology Co., Ltd.
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
K920820 Helena Laboratories MODIFICATION COLUMNMATE 1992-08-17
K991850 Biosafe Laboratories, Inc. SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC 1999-11-26
K171771 Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay 2017-12-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0018-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0019-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0020-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0021-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043654757. Last updated year: 2026. Please use registration number 3043654757 when referencing this establishment in official correspondence.
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