QUANTIMETRIX CORP.

Matched from indexed company URL: QUANTIMETRIX CORPORATION

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#

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