FDA Registration
Active
🇨🇦 Canada
Prolex E. coli O157 Latex Test Reagent Kit (50 tests)
Reg #: 8010383
·
FEI: 1000354384
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- pro-lab incorporated
- Registration Number
- 8010383
- FEI Number
- 1000354384
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 20 Mural Street, Unit #4
- City
- Richmond Hill Ontario
- Country
- CA
Owner / Operator
- Firm Name
- PRO-LAB, INC.
- Operator Number
- 8010383
- Address
- 20 MURAL ST., UNIT #4
- City
- RICHMOND HILL,
- State
- Ontario
- Postal Code
- L4B 1K3
- Country
- CA
US Agent
- Business Name
- Pro-Lab Incorporated
- Contact Name
- Robert J Rae
- Address
- 1301 Blue Ridge Dr, Suite 101
- City
- Georgetown
- State
- TX
- ZIP
- 78626
- Country
- US
- [email protected]
- Phone
- 512 8329145
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antisera, All Types, Escherichia Coli | GNA | Class 1 | Microbiology | No | 1994-05-02 |
Proprietary Names
Prolex E. coli O157 Latex Test Reagent Kit (50 tests)
Prolex E. coli O91 Latex Reagent
Prolex E. coli O145 Latex Reagent
Prolex E. coli O26 Latex Reagent
Prolex E. coli O157 Latex Test Reagent Kit (100 tests)
Prolex E. coli O45 Latex Reagent
Prolex E. coli Non-O157 Negative Control Latex Reagent
Prolex E. coli Non-O157 Identification Kit
Prolex E. coli O121 Latex Reagent
Prolex E. coli O103 Latex Reagent
Prolex E. coli O157 Latex Reagent Control Negative
Prolex E. coli O111 Latex Reagent
E. coli O157 Antiserum (3ml)
Establishment Types
Manufacture Medical Device