Hangzhou Clongene Biotech Co., Ltd.

No.1 Yichuang Road, Yuhang Sub-district,Yuhang District,Hangzhou 311121,China
Hangzhou,  311121

China
  • Booth: 1053

Hangzhou Clongene Biotech is a national high-tech enterprises has expertise in the R&D of Biological Raw Materials, Diagnostic Reagents and CDMO Services. Our main IVD reagents have obtained authoritative certifications including NMPA, FDA 510(k) clearances, TGA, CE and so on. The products have been sold well in more than 100 countries around the world.. Our CDMO services including antibody discovery, antibody expression, protein expression, and stable cell line development platforms.


 Press Releases

  • (May 13, 2024)
    Intended Use

    Multi-Drug Test Cassette/Dip Card/Easy Cup/Split Key Cup is a lateral flow immunoassay for the qualitative detection of any combination of Amphetamine (AMP)/Benzodiazepines (BZO)/Barbiturates (BAR)/Buprenorphine (BUP)/ Cocaine (COC)/ Cotinine (COT)/ 2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)/ Fentanyl (FYL)/ Ketamine (KET)/ Synthetic Cannabinoid (K2)/ Methamphetamine (mAMP/MET)/ Methylenedioxymethamphetamine (MDMA)/ Morphine (MOP)/ Methadone (MTD)/ Methaqualone (MQL)/ Opiates (OPI)/ Oxycodone (OXY)/ Phencyclidine (PCP)/ Propoxyphene (PPX)/ Tricyclic Antidepressants (TCA)/ Marijuana (THC)/ Tramadol (TRA) and their metabolites in human urine.

     


    Sample

    Urine

    Product Features

    • For the detection of any combination of 22 drugs and drug metabolites in human urine.
    • Fast results at 3-5 minutes.
    • Results are clearly visible and reliable.
    • High Accuracy.
    • Room temperature storage.
    Product Information
    Spreadhead Catalog No. Products Format Specifications Specimen Reading Time Cut-off Storage Condition Certification

    Multi-Drug Test Dip Card

    DDOA1204~1904 Multi-Drug 2~9 Drugs Test Dip Card

    Car Card

    25 tests/box Urine

    3-5 minutes

    Reference manual 4-30℃ CE
    DDOA1a04~1g04 Multi-Drug 10~16 Drugs Test Dip Card

    Multi-Drug Test Cassette

    DDOA1205~1605 Multi-Drug 2~6 Drugs Test Cassette Test Cassette 25 tests/box Urine

    3-5 minutes

    Reference manual 4-30℃ CE
    DDOA1212 Multi-Drug 2 Drugs Test Cassette (Multi-Line)
    DDOA1a55 Multi-Drug 10 Drugs Test Cassette (Multi-Line)

    Multi-Drug Test Easy Cup

    DDOA1307~1907 Multi-Drug 3~9 Drugs Test Easy Cup

     Easy  Cup

    25 tests/box Urine

    3-5 minutes

    Reference manual

    4-30℃ CE
    DDOA1a07~1f07

    Multi-Drug 10~15 Drugs Test Easy Cup

    Multi-Drug Test Split Easy Cup

    DDOA1867

    Multi-Drug 8 Drugs Test Split Key Cup (Multi-Line)

    Split  Key Cup

    25 tests/box Urine

    3-5 minutes

    Reference manual

    4-30℃ CE
    DDOA1a67 Multi-Drug 10 Drugs Test Split Key Cup (Multi-Line)

      These products can not be sold in the United States.

  • (May 13, 2024)
    Intended Use

    The HCG Pregnancy Rapid Tests is a lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (HCG) in human urine or serum. 


    Sample

    Urine, Serum

    Product Features

    • Easy handling, no instrument required.
    • Results at 3-5 minutes.
    • Results are clearly visible and reliable.
    • High Accuracy.
    • Room temperature storage.
    Product Information
    Catalog No. Specifications Format Specimen Reading Time Storage Condition Shelf Life Certification
    WHCG1001 50 tests/box Strip urine

    3-5 minutes

    4-30℃

    24 months CE
    WHCG1002 25 tests/box Cassette
    WHCG1003 20 tests/box Midstream
    WHCG2004 25 tests/box DipCard

    These products can not be sold in the United States.

     

  • Intended Use

    The COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab, nasal swab or oropharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider.


    Sample

    Nasopharyngeal Swab, Nasal Swab, Oropharyngeal Swab

    Product Features

    • Easy handling, no instrument required.
    • Support the detection of 3 different samples.
    • Instant results at 15 minutes.
    • Results are clearly visible and reliable.
    • High sensitivity and specificity.
    • Excellent performance compared to molecular methods.
    • Room temperature storage.
    Product Information
    Catalog No. Specifications Reaction Time Sensitivity Specificity Storage Condition Shelf Life Certification
    ICOV5002-A001 1 test/box 15 mins
     

     

    For nasopharyngeal swab: 

    96.0% (95% CI: 93.0%-97.8%)

     

    For nasal swab: 

    95.5% (95% CI: 89.8%-98.0%)

     

     

     

    For nasopharyngeal swab:

    100% (95% CI: 99.6%-100%)

     

    For nasal swab: 

    100% (95% CI: 99.2%-100%)

     

     

    4-30℃
     
    24 months
     
    CE
     
    ICOV5002-A005 5 tests/box
    ICOV5002-A025 25 tests/box

     

    These products can not be sold in the United States.

  • (May 13, 2024)
    Intended Use

    The LH Ovulation Rapid Test Strip/Cassette/Midstream is an immuno-chromatographic assay designed for qualitative detection and the rapid determination of luteinizing hormone (LH) in urine, aid for determine of the most fertile days during the cycle. The test is intended for in vitro diagnostic self-testing.


    Sample

    Urine

    Product Features

    • Easy handling, no instrument required.
    • Results at 3-5 minutes.
    • Results are clearly visible and reliable.
    • Room temperature storage.
    Product Information
    Catalog No. Specifications Format Specimen Reading Time Storage Condition Shelf Life Certification
    WSLH1001 50 tests/box Strip urine

    3-5 minutes

    4-30℃

    36 months CE
    WSLH1002 25 tests/box Cassette
    WSLH1003 20 tests/box Midstream

     

    These products can not be sold in the United States.

  • (May 13, 2024)
    INTENDED USE

    The CLUNGENE® FSH Menopause Rapid Test Strip is a rapid chromatographic immunoassay for the qualitative detection of Follicle Stimulating Hormone (FSH) in urine to aid in the detection of menopause. For self-testing and in vitro diagnostic use only. For over-the-counter use.

    WARNINGS AND PRECAUTIONS

     For in vitro diagnostic use only.
     Please read all the information in this leaflet before performing the test.
     Do not use the kit beyond the labeled expiry date.
     Do not open the sealed foil pouch until you are ready to start the test.
     Do not reuse the test strip.
     All urine specimens and used strip should be considered potentially infectious and avoided contact with skin.