FDA Registration
Active
🇺🇸 United States
JAS Diagnostics/Drew Scientific
Reg #: 1064608
·
FEI: 3003071743
·
Expires 2026
Products
9
Proprietary Names
7
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- JAS Diagnostics/Drew Scientific
- Registration Number
- 1064608
- FEI Number
- 3003071743
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6600 NW 14th Street, BAY 12
- City
- Plantation
- State
- FL
- ZIP
- 33313
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061511
Owner / Operator
- Firm Name
- JAS Diagnostics/Drew Scientific
- Operator Number
- 9042128
- Address
- 6600 NW 14th Street, BAY 12
- City
- Plantation
- State
- FL
- Postal Code
- 33313
- Country
- US
- Correspondent
- Jean F LaCroix
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 2013-01-31 |
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2016-08-09 |
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 2013-01-31 |
| Detergent | JCB | Class 1 | Pathology | No | 2016-08-09 |
| Calibrator For Red-Cell And White-Cell Counting | KSA | Class 2 | Hematology | No | 2016-08-09 |
| Calibrator For Platelet Counting | KRY | Class 2 | Hematology | No | 2016-08-09 |
| Calibrator For Cell Indices | KRX | Class 2 | Hematology | No | 2016-08-09 |
| Calibrator For Hemoglobin And Hematocrit Measurement | KRZ | Class 2 | Hematology | No | 2016-08-09 |
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2013-01-18 |
Proprietary Names
Differential Lyse (20L); Drew 3 Reagent Pac; Drew-3 Lytic Reagent; EX-Lyse; EX-PAC2
EX-Trol Plus Controls (Low, Normal, High)
Drew-3 Hematology Diluent; EX-ISO Hematology Diluent
Drew-3 Enzymatic Cleaner; E-Z Clean, EX-Ezyme, Drew Hematology Clean
EX-CAL Hematology Calibrator
D3 Hematology Analyzer Model D3
EX-Trol Controls (Low, Normal, High)
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility