QUANTIMETRIX CORPORATION

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

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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

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 Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Device Description : The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Device Description : The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Device Description : The QuanTscopics Urinalysis Microscopics Control is intended for use as quality 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.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Device Description : The QuanTscopics Urinalysis Microscopics Control is intended for use as quality 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.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Device Description : The Pediatric Bilirubin Control is intended as a means of monitoring various bil The Pediatric Bilirubin Control is intended as a means of monitoring various bilirubin assay methods to validate quantitation of patient samples. It is supplied as a liquid, 2x3mL vials per box. It is prepared from purified bilirubin in a human protein base, stabilizers and preservatives have been added.

Device Class : 1

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Device Description : The Pediatric Bilirubin Control is intended as a means of monitoring various bil The Pediatric Bilirubin Control is intended as a means of monitoring various bilirubin assay methods to validate quantitation of patient samples. It is supplied as a liquid, 3x3mL vials per box. It is prepared from purified bilirubin in a human protein base, stabilizers and preservatives have been added.

Device Class :

Duns Number: 010717890

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1