Prometheus Bio Inc.
Registered establishment in Hangzhou, Zhejiang, China. 12 device types.
Prometheus Bio Inc. is a contract manufacturer holding a current FDA establishment registration. The registration covers Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Methadone and 10 other device types. Its earliest product listing with the FDA dates from 2017.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3011559327 |
| FEI number | 3011559327 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 康永生物技术有限公司 |
|---|---|
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | No.3, 8th Street, Qiantang New Area, Hangzhou ,Zhejiang,310018,CHNIA |
| Postal code | 310018 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Enzyme Immunoassay, Amphetamine | Class 2 | UCP Rapid Drug SCR, UCP Rapid Drug Scree, UCP Compact Drug Tests, Number One Multi-Panel Drug Test Cup, UCP Home Drug Screening Tests, UCP Mini Drug Test Cups and 4 more | 2017 | 16 |
| Enzyme Immunoassay, Barbiturate | Class 2 | UCP Rapid Drug SCR, UCP Rapid Drug Scree, UCP Compact Drug Tests, Number One Multi-Panel Drug Test Cup, UCP Home Drug Screening Tests, UCP Mini Drug Test Cups and 5 more | 2017 | 12 |
| Enzyme Immunoassay, Benzodiazepine | Class 2 | UCP Rapid Drug SCR, UCP Rapid Drug Scree, UCP Compact Drug Tests, Number One Multi-Panel Drug Test Cup, UCP Home Drug Screening Tests, UCP Mini Drug Test Cups and 5 more | 2017 | 13 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | UCP Rapid Drug SCR, UCP Rapid Drug Scree, UCP Compact Drug Tests, Number One Multi-Panel Drug Test Cup, UCP Home Drug Screening Tests, UCP Mini Drug Test Cups and 5 more | 2017 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | UCP Rapid Drug SCR, UCP Rapid Drug Scree, UCP Compact Drug Tests, Number One Multi-Panel Drug Test Cup, UCP Home Drug Screening Tests, UCP Mini Drug Test Cups and 5 more | 2017 | 16 |
| Enzyme Immunoassay, Methadone | Class 2 | UCP Rapid Drug SCR, UCP Rapid Drug Scree, UCP Compact Drug Tests, Number One Multi-Panel Drug Test Cup, UCP Home Drug Screening Tests, UCP Mini Drug Test Cups and 5 more | 2017 | 11 |
| Enzyme Immunoassay, Opiates | Class 2 | UCP Rapid Drug SCR, UCP Rapid Drug Scree, UCP Compact Drug Tests, Number One Multi-Panel Drug Test Cup, UCP Home Drug Screening Tests, UCP Mini Drug Test Cups and 5 more | 2017 | 17 |
| Enzyme Immunoassay, Phencyclidine | Class U | UCP Rapid Drug SCR, UCP Rapid Drug Scree, UCP Compact Drug Tests, Number One Multi-Panel Drug Test Cup, UCP Home Drug Screening Tests, UCP Mini Drug Test Cups and 5 more | 2017 | 16 |
| Enzyme Immunoassay, Propoxyphene | Class 2 | UCP Compact Drug Tests, Number One Multi-Panel Drug Test Cup, UCP Home Drug Screening Tests, UCP Mini Drug Test Cups, UCP Multiple Drug Screen Test Cups, UCP Multi-Drug Test Key Cups and 2 more | 2017 | 10 |
| Gas Chromatography, Methadone | Class 2 | UCP Compact Drug Tests, UCP Home Drug Screening Test Cups | 2017 | 1 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | Class 2 | UCP Compact Drug Tests, Number One Multi-Panel Drug Test Cup, UCP Home Drug Screening Tests, UCP Mini Drug Test Cups, UCP Home Drug Screening Test Cups, Number One Flat Multi-Panel Drug Test Cup and 5 more | 2017 | 9 |
| Thin Layer Chromatography, Methamphetamine | Class 2 | UCP Rapid Drug SCR, UCP Rapid Drug Scree, UCP Compact Drug Tests, Number One Multi-Panel Drug Test Cup, UCP Home Drug Screening Tests, UCP Mini Drug Test Cups and 5 more | 2017 | 12 |
Clearances
No clearance names Prometheus Bio Inc. as applicant. 12 are held by another company 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 |
|---|---|---|---|---|
| K151213 | 2015-08-21 | DKZ | Special | UCP Biosciences, Inc. |
| K132812 | 2014-03-06 | DKZ | Traditional | UCP Biosciences, Inc. |
| K131811 | 2013-07-19 | DKZ | Special | UCP Biosciences, Inc. |
| K130463 | 2013-05-15 | DKZ | Traditional | UCP Biosciences, Inc. |
| K123863 | 2013-01-09 | DKZ | Special | UCP Biosciences, Inc. |
| K122419 | 2012-11-30 | DKZ | Traditional | UCP Biosciences, Inc. |
| K110515 | 2011-04-20 | DIS | Special | UCP Biosciences, Inc. |
| K091612 | 2010-02-24 | DJG | Traditional | UCP Biosciences, Inc. |
| K091588 | 2009-09-04 | DKZ | Traditional | UCP Biosciences, Inc. |
| K072062 | 2007-09-20 | LFG | Special | UCP Biosciences, Inc. |
| K061457 | 2006-08-21 | LFG | Traditional | UCP Biosciences, Inc. |
| K050540 | 2005-04-29 | DKZ | Traditional | UCP Biosciences, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Main products | Drug abuse testing products, Women’s health diagnostics, Infectious disease tests, Cardiac markers, Tumor markers |
| Certifications | ISO 13485:2003, FDA, CE, NMPA |
| Export markets | United States, Europe, Australia, New Zealand |
| OEM and ODM | Offered |
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.