QUANTIMETRIX CORP.

Matched from indexed company URL: Quantimetrix Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20207152020715QUANTIMETRIX CORP.1N2026-01-012005 Manhattan Beach Blvd REDONDO BEACH CA US 90278

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00896863002004Dropper 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) 536-0006sales@quantimetrix.com
00896863002011Dropper 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) 536-0006sales@quantimetrix.com
00896863002042Chromascopics 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) 536-0006sales@quantimetrix.com
00896863002066Dropper 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) 536-0006sales@quantimetrix.com
00896863002073Dropper 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) 536-0006sales@quantimetrix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
340901591494480K970862SPINALSCOPICSJJY1997-04-08
340901095704508K943925SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTINGJJR1994-10-04
340901157718350K925256QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROLJJY1993-03-01
340901321565157K913346QUANTIMETRIX AMMONIA CONTROLSJJX1991-09-25
340901712211389K904603QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEMCEK1991-01-25
340902062658979K874890QUANTIMETRIX URINE DIPSTICK CONTROLJJW1988-01-21
340901319934406K860942QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUIDJJY1986-05-23
340901219128885K853932QUANTTEST TOTAL PROTEIN ASSAYCEK1985-12-19
340901810622466K831527SPINAL FLUID TOTAL PROTEIN CONTROLJJX1983-07-18
340901033273992K831526URINE TOTAL PROTEIN CONTROLJJW1983-08-12
340901988255693K152117Dropper hsCRP High Sensitivity CRP ControlJJX2016-04-21
340902072590150K142262AUTION CHECK PLUSJJW2015-04-10
340901564541851K113177COMPLETE D 25-OH VITAMIN D CONTROLJJX2012-05-10
340901205237117K103744DROPPER A1C DIABETES CONTROLJJX2011-05-12
340901544897953K013662MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONSJHO2002-03-08
340901295232601K010337LIPOPRINT SYSTEM, LDL SUBFRACTIONSJHO2001-07-25
340901647388968
340901121014723
340901258134395
340901284515800
340901409293972

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJX52016-04-21
JJW32015-04-10
JJY31997-04-08
CEK31991-01-25
JHO22002-03-08
JJR11994-10-04

PMN#

45 records. Showing 1-40. Next

GUDID#

Chromascopics Control Level 1&2 Set 2x25mL (International) - 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 2x25mL of each level per bag. 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.

QUANTIMETRIX CORPORATION

2023-05-04

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.

QUANTIMETRIX CORPORATION

2018-09-26

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.

QUANTIMETRIX CORPORATION

2018-09-26

Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL - The Dip&Spin Urinalysis Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed methods, and as a control for confirmatory tests. It is also intended as a means of validating the processing and centrifugation of patient urine samples prior to microscopic evaluation of urine sediment. The controls are supplied liquid, ready-to-use in two levels. They do not require reconstitution or dilution. They are prepared from human urine to which stabilized human red and white blood cells, calcium oxalate crystals, and other compounds have been added to produce the desired reactions when tested by methods described in the product insert.

QUANTIMETRIX CORPORATION

2019-03-13

Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 2x5mL - The Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are supplied in two levels, liquid, ready-to-use, requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth.

QUANTIMETRIX CORPORATION

2018-09-26

Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 4x120mL - The Dip&Spin Urinalysis Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed methods, and as a control for confirmatory tests. It is also intended as a means of validating the processing and centrifugation of patient urine samples prior to microscopic evaluation of urine sediment. The controls are supplied liquid, ready-to-use in two levels. They do not require reconstitution or dilution. They are prepared from human urine to which stabilized human red and white blood cells, calcium oxalate crystals, and other compounds have been added to produce the desired reactions when tested by methods described in the product insert.

QUANTIMETRIX CORPORATION

2018-09-26

Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 10x5mL - The Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are supplied in two levels, liquid, ready-to-use, requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth.

QUANTIMETRIX CORPORATION

2018-09-26

Dipper Urinalysis Dipstick Control Level 2 Set 6x15mL - The Dipper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are supplied in two levels as 6x15mL, three tubes of each level or 6x15mL level 2 only. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth.

QUANTIMETRIX CORPORATION

2018-09-26

Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL - The Dipper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are supplied in two levels as 6x15mL, three tubes of each level or 6x15mL level 2 only. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth.

QUANTIMETRIX CORPORATION

2018-09-26

Dropper Urinalysis Dipstick Control Level 1&2 Set 2x25mL - The Dropper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth.

QUANTIMETRIX CORPORATION

2018-09-26

Dropper Urinalysis Dipstick Control Level 1&2 Set 4x25mL - The Dropper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth.

QUANTIMETRIX CORPORATION

2018-09-26

Microbumin Microalbumin Control Level 1&2 Set 10x7mL - The Microbumin Microalbumin Control is intended as a means of monitoring various microalbumin assay methods to validate quantitation of patient samples. It is supplied in two levels, 5x7mL each level per box. They are ready-to-use, liquid, requiring no reconstitution. They are prepared from human urine, fortified to target levels with human albumin and creatinine. Preservatives have been added to inhibit microbial growth.

QUANTIMETRIX CORPORATION

2018-09-26

Spinalscopics Control Level 2 Set 3x3mL - Spinalscopics Spinal Fluid Cell Count Control is intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient CSF samples. Total cell counts are performed in a counting chamber with undiluted CSF. They are supplied in two levels, 3x3mL bottles per level per box. The controls are ready-to-use liquid, requiring no reconstitution or dilution. They are prepared in a human protein matrix fortified to target levels with purified chemicals and stabilized human red and white blood cells. Preservatives have been added to inhibit microbial growth.

QUANTIMETRIX CORPORATION

2018-09-26

Spinalscopics Control Level 1 Set 3x3mL - Spinalscopics Spinal Fluid Cell Count Control is intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient CSF samples. Total cell counts are performed in a counting chamber with undiluted CSF. They are supplied in two levels, 3x3mL bottles per level per box. The controls are ready-to-use liquid, requiring no reconstitution or dilution. They are prepared in a human protein matrix fortified to target levels with purified chemicals and stabilized human red and white blood cells. Preservatives have been added to inhibit microbial growth.

QUANTIMETRIX CORPORATION

2018-09-26

Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL - The Complete D 25-OH Vitamin D control is intended to monitor the performance of clinical assays used to quantitate total 25-OH Vitamin D. It is supplied in two levels, 3mL per vial. Each kit contains 2 vials of level 1 and 2 vials of level 2 controls. The controls are liquid, ready to use and require no reconstitution of dilution. The controls are prepared in a human serum matrix fortified with analytes and preservatives. This control contains both 25-OH Vitamin D2 and D3, and when combined represent clinically relevant levels of Total Vitamin D.

QUANTIMETRIX CORPORATION

2018-09-26

Chromascopics Control Level 1&2 Set 4x120mL (International) - The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus Automated Urine Chemistry Analyzer and Atellica 800 and 1500 systems. It is also compatible with Siemens urinalysis dipsticks, 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.

QUANTIMETRIX CORPORATION

2018-09-26

Sweat Control Level 1, 2, & 3 Set 9x3mL - The Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of monitoring the measurement of conductivity and osmolality by cystic fibrosis screening procedures and to validate the analysis of Chloride, Potassium, and Sodium by confirmatory methods used to quantitate patient samples. They are liquid, ready-to-use, requiring no reconstitution or dilution. They are supplied in three levels, nine vials per box, 3x3mL each level. They are prepared in an aqueous simulated human sweat matrix to which preservatives have been added.

QUANTIMETRIX CORPORATION

2018-09-26

Dipper POCT Level 1&2 Set 20x1.5mL - The Dipper POCT is a two level urinalysis dipstick control. Each level is contained in a single-use plastic pouch filled with 1.5mL of liquid control material that is ready-to-use, requiring no reconstitution of dilution. The controls are formulated from a simulated urine matrix fortified with preservatives and stabilizers to maintain product integrity and inhibit microbial growth. Each control level is formulated to target levels with compounds that produce the desired reaction when tested by methods indicated in the product insert.

QUANTIMETRIX CORPORATION

2018-09-26

Dipper POCT Level 1&2 Set 62x1.5mL - The Dipper POCT is a two level urinalysis dipstick control. Each level is contained in a single-use plastic pouch filled with 1.5mL of liquid control material that is ready-to-use, requiring no reconstitution of dilution. The controls are formulated from a simulated urine matrix fortified with preservatives and stabilizers to maintain product integrity and inhibit microbial growth. Each control level is formulated to target levels with compounds that produce the desired reaction when tested by methods indicated in the product insert.

QUANTIMETRIX CORPORATION

2018-09-26

Lipoprint LDL Subfractions Kit 4x25 tests - The Lipoprint System LDL Subfractions Kit is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions from VLDL to HDL) in fasting serum or plasma with a Total Cholesterol concentration of >100mg/dL. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment, and clinical evaluation.

QUANTIMETRIX CORPORATION

2018-09-26

QuanTscopics Control Level 2 Set 4x120mL - The QuanTscopics Urinalysis Microscopics Control is intended for use as quality control material for the microscopic evaluation of various urine sediment methods. It is supplied in two level, 4x120mL bottles per level per box. It is liquid, ready-to-use, requiring no reconstitution or dilution. The control is made from human urine to which stabilized human red blood cells, human white blood cells, and uric acid, calcium oxalate, and calcium phosphate crystals have been added.

QUANTIMETRIX CORPORATION

2018-09-26

QuanTscopics Control Level 1 Set 4x120mL - The QuanTscopics Urinalysis Microscopics Control is intended for use as quality control material for the microscopic evaluation of various urine sediment methods. It is supplied in two level, 4x120mL bottles per level per box. It is liquid, ready-to-use, requiring no reconstitution or dilution. The control is made from human urine to which stabilized human red blood cells, human white blood cells, and uric acid, calcium oxalate, and calcium phosphate crystals have been added.

QUANTIMETRIX CORPORATION

2018-09-26

44 records. Showing 1-40. Next