FDA Registration
Active
🇺🇸 United States
QUANTIMETRIX CORP.
Reg #: 2020715
·
FEI: 2020715
·
Expires 2026
Products
7
Proprietary Names
28
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- QUANTIMETRIX CORP.
- Registration Number
- 2020715
- FEI Number
- 2020715
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2005 Manhattan Beach Blvd
- City
- REDONDO BEACH
- State
- CA
- ZIP
- 90278
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142262
Owner / Operator
- Firm Name
- QUANTIMETRIX CORP.
- Operator Number
- 2020715
- Address
- 2005 MANHATTAN BEACH BLVD., --
- City
- Redondo Beach
- State
- CA
- Postal Code
- 90278
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2022-05-21 |
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2017-08-14 |
| Electrolyte Controls (Assayed And Unassayed) | JJR | Class 1 | Clinical Chemistry | No | 2007-10-16 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2007-11-10 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2007-11-10 |
| Electrophoretic Separation, Lipoproteins | JHO | Class 1 | Clinical Chemistry | No | 1986-11-07 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2007-11-10 |
Proprietary Names
Dipper POCT Urinalysis Dipstick Control
CHROMASCOPICS Urinalysis Control with Microscopics
AUTION CHECK Plus
AUTION CHECK Plus
Aution Check Plus
Microbumin Microalbumin Control
Dropper Urine Chemistry Control
Sweat Control for Cystic Fibrosis Testing
Spinalscopics® Spinal Fluid Cell Count Control
Ammonia/Alcohol Control
Dropper® A1c Diabetes Control
LIPOPRINT LDL KIT
LIPOPRINT SYSTEM
Dropper® Spinal Fluid Control
Spinal Fluid Control
Complete D 25-OH Vitamin D Control
Quan Ttest Red Total Protein
Dropper Urinalysis Dipstick Control
Dipper Urinalysis Dipstick Control
Dip&Spin Urinalysis Dipstick Microscopics Control
Dropper Plus Point -of Care Urinalysis Dipstick Control
QuanTscopics® Urinalysis Microscopics Control
Liposure Serum Lipoprotein Control, Level 1
LIPOPRINT® Lipoprotein Subfractions, Testing System
LIPOPRINT® LDL Subfractions Kit
Bilirubin Control Pediatric
Quantimetrix QuanTtest Red Protein Assay System
QUANTTEST TOTAL PROTEIN
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only