Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016741564

FEI Number

3016741564

Entity Name

JINAN BABIO BIOTECHNOLOGY CO.,LTD.

City/State/Country

Jinan City Shandong, CN

Establishment Address

303, Building 5 of SME Industrialization Base of Biomedical Park, 1777 Dazheng Road, High-tech Zone, Jinan City Shandong 250101, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

JINAN BABIO BIOTECHNOLOGY CO.,LTD. (Owner Number: 10066753)

Owner / Operator Contact Address

303, Building 5 of SME Industrialization Base of Biomedical Park, 1777 Dazheng Road, High-tech Zone, Jinan City, CN-SD 250101, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Modified Cary-Blair Transport Media Cary-Blair Transport Media Hematoxylin eosin staining solution kit Liquid Amies Media Virus Transport Kit (Non-Inactivated) Viral Transport Tube Premium oil mirror oil XLD Agar Medium Thiosulfate Citrate Bile Salts Sucrose Agar Medium Salmonella Shigella Agar Intestinal bacteria agar medium Liu's Dye Solution Kit Jimsa Dye Solution Kit Reichs-Giemsa Dye Solution Rapid Gram dye solution kit Acid fast staining solution kit Acid fast staining solution (fluorescence method) kit Liquid Amies Media Virus Transport Kit (Non-Inactivated) Sabouraud Dextrose Agar Medium(SDA) MacConkey Agar Sabouraud Agar Medium Disposable Sampling Swab (Sterile) Disposable Sampling Swab Liu's Dye Solution Kit Pap staining solution kit Normal Saline Vaginal microbiome detection kit (dry chemical method) Potato Dextrose AGAR Medium (PDA) Mold Detection Plate Mycoplasma Pneumoniae lgM Test Kit (Colloidal Gold) Hematoxylin eosin staining solution kit Reticulocyte staining solution kit Liu's Dye Solution Kit Babio® Virus Transport Kit (Non-Inactivated) Virus Transport Kit (Inactivated) Columbia Blood Agar Medium

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2021-01-17
HYJ	Hematoxylin	Hematology	Class 1	864.1850	2024-01-09
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-11-17
IJZ	Oil, Clearing	Pathology	Class 1	864.4010	2024-02-21
JSH	Culture Media, Non-Selective And Differential	Microbiology	Class 1	866.2320	2025-08-19
HYF	Giemsa Stain	Hematology	Class 1	864.1850	2024-01-08
HYI	Iodine, Grams	Hematology	Class 1	864.1850	2024-01-08
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2023-11-21
JSJ	Culture Media, Selective And Non-Differential	Microbiology	Class 1	866.2360	2025-08-19
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-05-19
HZJ	Stain, Papanicolau	Hematology	Class 1	864.1850	2024-01-08
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2021-05-25
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2025-02-24
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-04-02
KIW	Kit, Mycoplasma Detection	Hematology	Class 1	864.2360	2022-06-14
HYB	Eosin Y	Hematology	Class 1	864.1850	2024-01-08
GJH	Stain, Reticulocyte	Hematology	Class 1	864.1850	2024-01-09
QMC	Transport Medium, Notified Per The Vtm Guidance	Microbiology	Class 1	866.2390	2021-04-21
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	Class 2	866.2950	2021-07-30
KZI	Culture Media, Enriched	Microbiology	Class 1	866.2330	2025-08-19

Official Correspondent

Xiaotong Zhou

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (509) 5816099

Related Public Records

Same Entity

JINAN BABIO 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
K863524	Bd Becton Dickinson Vacutainer Systems Preanalytic	REGAN-LOWE CHARCOAL AGAR	1986-09-19
K770926	Analytical Products, Inc.	SUSPENSION SALINE, API 20E	1977-06-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.
Z-0024-05	Remel, Inc.	1	Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016741564. Last updated year: 2026. Please use registration number 3016741564 when referencing this establishment in official correspondence.