FDA Registration
Active
🇨🇦 Canada
Prolex Legionella pneumophila Serogroup 6 Latex Reagent
Reg #: 8010383
·
FEI: 1000354384
·
Expires 2025
Products
1
Proprietary Names
39
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 |
|---|---|---|---|---|---|
| Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | LHL | Class 2 | Microbiology | No | 2001-08-09 |
Proprietary Names
Prolex Legionella pneumophila Serogroup 6 Latex Reagent
Legionella pneumophila Serogroup 4 DFA Reagent
Legionella pneumophila Serogroup 5 DFA Reagent
Prolex Legionella pneumophila Serogroup 8 Latex Reagent
Prolex Legionella pneumophila Serogroup 10 Latex Reagent
Legionella pneumophila Serogroup 7 DFA Reagent
Prolex L. pneumophila Serogroup 1 Negative Control Latex Reagent
Prolex Legionella pneumophila Serogroup 7 Latex Reagent
Legionella pneumophila Positive Control Serogroups 1-14
Legionella pneumophila Serogroup 12 DFA Reagent
Legionella pneumophila Serogroup 3 DFA Reagent
Prolex Legionella micdadei
Prolex Legionella pneumophila Serogroup 11 Latex Reagent
Legionella pneumophila Serogroup 2 DFA Reagent
Legionella micdadei DFA Reagent
Prolex Legionella pneumophila Serogroup 13 Latex Reagent
Legionella pneumophila Serogroup 8 DFA Reagent
Legionella DFA Negative Control
Prolex Legionella pneumophila Serogroup 3 Latex Reagent
Legionella pneumophila Serogroup 10 DFA Reagent
Prolex Legionella pneumophila Serogroup 4 Latex Reagent
Legionella pneumophila Serogroup 6 DFA Reagent
Phosphate Buffered Saline (pH 7.6)
Legionella pneumophila Serogroup 11 DFA Reagent
Prolex Legionella pneumophila Serogroup 5 Latex Reagent
Legionella pneumophila Serogroup 13 DFA Reagent
Prolex L. pneumophila Serogroup 1 Positive Control Latex Reagent
Legionella pneumophila Serogroup 9 DFA Reagent
Prolex Legionella pneumophila Serogroup 2 Latex Reagent
Prolex Legionella pneumophila Serogroup 12 Latex Reagent
Legionella DFA Mounting Medium
Legionella pneumophila Serogroups 1-14 DFA Kit (50 tests)
Prolex Legionella pneumophila Negative Control Latex Reagent
Prolex Legionella pneumophila Serogroups 1-14 Positive Control
Prolex Legionella pneumophila Serogroup 14 Latex Reagent
Prolex Legionella pneumophila Serogroup 1 Latex Reagent (Monoclonal)
Prolex Legionella pneumophila Serogroup 9 Latex Reagent
Legionella pneumophila Serogroup 1 DFA Kit (50 tests)
Legionella pneumophila Serogroup 14 DFA Reagent
Establishment Types
Manufacture Medical Device