QUANTIMETRIX CORPORATION

Address:2005 Manhattan Beach Blvd,REDONDO BEACH,CA,90278,US

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Device Description : The Microbumin Microalbumin Control is intended as a means of monitoring various 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.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

Device Description : The Dropper Urinalysis Dipstick Control is intended as a control for urinalysis 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.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

Device Description : The Dropper Urinalysis Dipstick Control is intended as a control for urinalysis 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.

Device Class : 1

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

Device Description : The Dipper Urinalysis Dipstick Control is intended as a control for urinalysis r 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.

Device Class : 1

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

Device Description : The Dipper Urinalysis Dipstick Control is intended as a control for urinalysis r 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.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

Device Description : The Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a cont 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.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

Device Description : The Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a cont 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.

Device Class : 1

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

Device Description : The Dip&Spin Urinalysis Control is intended as a control for urinalysis reagent 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.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Device Description : The Dropper Urine Chemistry Control is intended for use as a control for human u The Dropper Urine Chemistry Control is intended for use as a control for human urine assay methods. It is supplied as a ready-to-use liquid requiring no reconstitution. They are prepared from human urine and fortified to target levels with human proteins and reagent grade chemicals. Preservatives have been added to inhibit microbial growth.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

Device Description : The Dropper Urine Chemistry Control is intended for use as a control for human u The Dropper Urine Chemistry Control is intended for use as a control for human urine assay methods. It is supplied as a ready-to-use liquid requiring no reconstitution. They are prepared from human urine and fortified to target levels with human proteins and reagent grade chemicals. Preservatives have been added to inhibit microbial growth.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1