FDA Registration
Active
🇨🇳 China
Prometheus Bio Inc.
Reg #: 3011559327
·
FEI: 3011559327
·
Expires 2026
Products
12
Proprietary Names
12
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- Prometheus Bio Inc.
- Registration Number
- 3011559327
- FEI Number
- 3011559327
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.3, 8th Street, Qiantang New Area, Hangzhou ,Zhejiang,310018,CHNIA
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K091588
Owner / Operator
- Firm Name
- Prometheus Bio Inc.
- Operator Number
- 10055881
- Address
- No.3, 8th Street, Qiantang New Area,
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310018
- Country
- CN
- Correspondent
- jane chen
US Agent
- Business Name
- Saxon Interglobal Associates, Limited Company
- Contact Name
- Jennifer Saxon
- Address
- 30 N Gould Suite 5135
- City
- Sheridan
- State
- WY
- ZIP
- 82801
- Country
- US
- [email protected]
- Phone
- 307 4290222
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gas Chromatography, Methadone | DMB | Class 2 | Clinical Toxicology | No | 2017-10-15 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2017-10-15 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2017-10-15 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2017-10-15 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2017-10-15 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2017-10-15 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2017-10-15 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2017-10-15 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2017-10-15 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2017-10-15 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2017-10-15 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2017-10-15 |
Proprietary Names
UCP Home Drug Screening Test Cups
UCP Mini Drug Test Cups
UCP Multi-Drug Test Key Cups
UCP Multiple Drug Screen Test Cups
UCP Compact Drug Tests
Number One Multi-Panel Drug Test Cup
UCP RAPID DRUG SCR
UCP RAPID DRUG SCREE
UCP RAPID DRUG SCREENING
UCP Drug Screening Test Cups
Number One Flat Multi-Panel Drug Test Cup
UCP Home Drug Screening Tests
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device