Dropper HsCRP High Sensitivity CRP Control
Quantimetrix Corporation
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2020715 | 2020715 | QUANTIMETRIX CORP. | 1 | N | 2026-01-01 | 2005 Manhattan Beach Blvd REDONDO BEACH CA US 90278 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00896863002004 | Dropper Spinal Fluid Control Level 1 Set 3x3mL - The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | (310) 536-0006 | sales@quantimetrix.com |
| 00896863002011 | Dropper Spinal Fluid Control Level 2 Set 3x3mL - The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | (310) 536-0006 | sales@quantimetrix.com |
| 00896863002042 | Chromascopics Control Level 1&2 Set 4x120mL (Domestic) - The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus Automated Urine Chemistry Analyzer. It is also compatible with Siemens urinalysis dipsticks and Clinitek analyzers, confirmatory tests, and qualitative methods. It may also be used as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment. It is supplied as a liquid, ready-to-use control in two levels, configured with 2x120mL of each level per box. It does not required reconstitution or dilution. They are prepared from human urine to which stabilized human red and white blood cells, calcium oxalate crystals, non-pathogenic bacteria, and other compounds have been added to produce desired reactions when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth. | (310) 536-0006 | sales@quantimetrix.com |
| 00896863002066 | Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL - The Dropper A1c Diabetes Control is intended for the quality control of analytical procedures used to quantitate HbA1c. It is supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. It consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the methods indicated in the product insert. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth. | (310) 536-0006 | sales@quantimetrix.com |
| 00896863002073 | Dropper Spinal Fluid Control Level 1&2 Set 2x3mL - The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | (310) 536-0006 | sales@quantimetrix.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 34090 | 1591494480 | K970862 | SPINALSCOPICS | JJY | 1997-04-08 |
| 34090 | 1095704508 | K943925 | SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING | JJR | 1994-10-04 |
| 34090 | 1157718350 | K925256 | QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL | JJY | 1993-03-01 |
| 34090 | 1321565157 | K913346 | QUANTIMETRIX AMMONIA CONTROLS | JJX | 1991-09-25 |
| 34090 | 1712211389 | K904603 | QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM | CEK | 1991-01-25 |
| 34090 | 2062658979 | K874890 | QUANTIMETRIX URINE DIPSTICK CONTROL | JJW | 1988-01-21 |
| 34090 | 1319934406 | K860942 | QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID | JJY | 1986-05-23 |
| 34090 | 1219128885 | K853932 | QUANTTEST TOTAL PROTEIN ASSAY | CEK | 1985-12-19 |
| 34090 | 1810622466 | K831527 | SPINAL FLUID TOTAL PROTEIN CONTROL | JJX | 1983-07-18 |
| 34090 | 1033273992 | K831526 | URINE TOTAL PROTEIN CONTROL | JJW | 1983-08-12 |
| 34090 | 1988255693 | K152117 | Dropper hsCRP High Sensitivity CRP Control | JJX | 2016-04-21 |
| 34090 | 2072590150 | K142262 | AUTION CHECK PLUS | JJW | 2015-04-10 |
| 34090 | 1564541851 | K113177 | COMPLETE D 25-OH VITAMIN D CONTROL | JJX | 2012-05-10 |
| 34090 | 1205237117 | K103744 | DROPPER A1C DIABETES CONTROL | JJX | 2011-05-12 |
| 34090 | 1544897953 | K013662 | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS | JHO | 2002-03-08 |
| 34090 | 1295232601 | K010337 | LIPOPRINT SYSTEM, LDL SUBFRACTIONS | JHO | 2001-07-25 |
| 34090 | 1647388968 | ||||
| 34090 | 1121014723 | ||||
| 34090 | 1258134395 | ||||
| 34090 | 1284515800 | ||||
| 34090 | 1409293972 |
Quantimetrix Corporation
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