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QINGDAO HIGHTOP BIOTECH CO., LTD.

China·CN-MF-000016890

Last updated September 17, 2026

Information

Country
China
Address
No.369, Hedong Road, Qingdao, Shandong, China
Website
www. hightopbio.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
—
PRRC Contact
Yunlei Li
EUDAMED SRN
CN-MF-000016890
FDA FEI Number
3014223276
DUNS Number
—

Catalogue (17)

DeviceModel / ReferenceRegistriesClassStatus
CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold) /
EUDAMED
IVD Annex II List BActive
TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold) /
EUDAMED
IVD Annex II List BActive
HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx K220685
FDA 510(k)
Class IIActive
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel K241969
FDA 510(k)
Class IIActive
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream K192123
FDA 510(k)
Class IIActive
CMV Cytomegalovirus Antibody IgM/IgG Rapid Test Kit (Colloidal Gold) /
EUDAMED
IVD Annex II List BActive
Strep A Antigen Rapid Test (Immunochromatography) /
EUDAMED
IVD GeneralActive
Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold) /
EUDAMED
IVD Annex II List BActive
One Step LH Ovulation Rapid Test Kit(Colloidal Gold) /
EUDAMED
IVD devices for self-testingActive
TOXO Toxoplasma Antibody IgG Rapid Test Kit (Colloidal Gold) /
EUDAMED
IVD Annex II List BActive
SARS-CoV-2/Flu A+B/AdV/RSV Antigen Rapid Test /
EUDAMED
IVD GeneralActive
TOXO Toxoplasma Antibody IgM Rapid Test Kit (Colloidal Gold) /
EUDAMED
IVD Annex II List BActive
SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test /
EUDAMED
IVD GeneralActive
FOB Fecal Occult Blood Rapid Test /
EUDAMED
IVD GeneralActive
One Step HCG Urine Pregnancy Rapid Test Kit (Colloidal Gold) /
EUDAMED
IVD devices for self-testingActive
CMV Cytomegalovirus Antibody IgM/IgG Rapid Test Kit (Colloidal Gold) /
EUDAMED
IVD Annex II List BActive
RV Rubella Antibodies IgM/IgG Rapid Test Kit(Colloidal Gold) /
EUDAMED
IVD Annex II List BActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Qingdao Hightop Biotech Co., Ltd. US