Nantong Egens Biotechnology Co., Ltd.
Registered establishment in Nantong, Jiangsu, China. 7 device types, 1 clearance.
Nantong Egens Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Enzyme Immunoassay, Cannabinoids, Gas Chromatography, Methamphetamine and 5 other device types. Its earliest product listing with the FDA dates from 2012.
Registration
| Registered name | NANTONG EGENS BIOTECHNOLOGY CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006361161 |
| FEI number | 3006361161 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 南通伊仕生物技术股份有限公司 |
|---|---|
| Source | Qianzhan company data |
Location
| City | Nantong |
|---|---|
| Province | Jiangsu |
| Address | Building 15, Building 12 (west), No. 1692 Xinghu Avenue |
| Postal code | 226010 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Enzyme Immunoassay, Cannabinoids | Class 2 | EGENS Urine Test Marijuana (THC) EGENS Urine Test MDMA | 2015 | 18 |
| Gas Chromatography, Methamphetamine | Class 2 | EGENS Urine Test Cup Morphine → Methamphetamine EGENS Urine Test DipCard Morphine → Methamphetamine, EGENS Urine Test Marijuana (THC) EGENS Urine Test MDMA | 2015 | 10 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | EGENS Pregnancy Test Midstream II, EGENS Pregnancy Test Midstream I, EGENS One Step HCG Urine Pregnancy Test Kit (Strip, Cassette, Midstream) | 2013 | 30 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | EGENS Follicle Stimulating Hormone (FSH) Test Cassette, EGENS Follicle Stimulating Hormone (FSH) Test Strip, EGENS Follicle Stimulating Hormone (FSH) Test Midstream | 2013 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | EGENS Ovulation (LH) Test (strip, cassette, midstream) | 2012 | 38 |
| Thin Layer Chromatography, Morphine | Class 2 | EGENS Urine Test Cup Morphine → Methamphetamine EGENS Urine Test DipCard Morphine → Methamphetamine | 2015 | 4 |
| Visual, Pregnancy Hcg, Prescription Use | Class 2 | EGENS One Step HCG Urine Pregnancy Test Kit (Strip, Cassette, Midstream) | 2013 | 16 |
Clearances
1 clearance names Nantong Egens Biotechnology Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232864 | 2024-01-26 | LCX | Traditional | This company |
| K152643 | 2015-11-02 | LDJ | Traditional | Nantong Egens Biotech Co., Ltd. |
| K151557 | 2015-07-16 | DNK | Traditional | Nantong Egens Biotech Co., Ltd. |
| K123050 | 2013-02-05 | LCX | Traditional | Nantong Biotechnology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 19,500 sqm |
|---|---|
| Main products | Fertility test kits, Infectious disease test kits, Tumor marker test kits, Drugs of abuse test kits, ELISA/CLIA test kits |
| Certifications | ISO 9001, ISO 13485, CMDR, ISO 14001, OSHAS 18001, GMP |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.