Hangzhou Clongene Biotech Co., Ltd.

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

China
https://en.clongene.com/

• 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

• Multi-Drug Test (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.

• HCG Pregnancy Rapid Test (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.

   

• COVID-19 Antigen Rapid Test (Type A) (May 13, 2024)
  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.

• LH Ovulation Rapid Test (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.

• FSH Menopause Rapid Test (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.