NOVA BIOMEDICAL CORPORATION

Address:200 Prospect St,WALTHAM,MA,02454,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

ELECTRODE, ION SPECIFIC, SODIUM (JGS) (8) ELECTRODE, ION SPECIFIC, POTASSIUM (CEM) (8) ELECTRODE, ION-SPECIFIC, CHLORIDE (CGZ) (8) Assay, porphyrin, spectrophotometry, lithium (NDW) (6) DEVICE, HEMATOCRIT MEASURING (JPI) (6) ELECTRODE, ION SPECIFIC, CALCIUM (JFP) (4) PH RATE MEASUREMENT, CARBON-DIOXIDE (JFL) (3) ELECTRODE, ION SPECIFIC, UREA NITROGEN (CDS) (3) GLUCOSE OXIDASE, GLUCOSE (CGA) (3) Multi-analyte controls, all kinds (assayed) (JJY) (2) ELECTRODE, ION SPECIFIC, MAGNESIUM (CFA) (2) ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH (CHL) (2) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (1) ELECTRODE, ION BASED, ENZYMATIC, CREATININE (CGL) (1)

Premarket Exempt

Clear

NOVA - 00385480130493 Catalog Number : 13049

Device Description : NOVA 1/5/8/11/13/14 HEMATOCRIT SENSOR

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : JPI

Prescription Use : Yes

Device Count : 1

NOVA - 00385480131414 Catalog Number : 13141

Device Description : NOVA 1/5/11 S LINE

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : JPI, CGZ, JGS, NDW, CEM

Prescription Use : Yes

Device Count : 6

NOVA - 00385480131421 Catalog Number : 13142

Device Description : NOVA 12/14/16 S LINE

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : CGL, CGZ, CEM, CGA, JGS, JFL, CDS, JPI

Prescription Use : Yes

Device Count : 6

NOVA - 00385480131438 Catalog Number : 13143

Device Description : NOVA 8/13 S LINE

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : CGZ, JPI, CFA, CEM, JGS, JFP, CHL, NDW

Prescription Use : Yes

Device Count : 6

Nova - 00385480131773 Catalog Number : 13177

Device Description : GLUCOSE/BUN OVER-RANGE SOLUTION

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 30

NOVA - 00385480131926 Catalog Number : 13192

Device Description : NOVA 12 TUBING HARNESS WITHOUT DILUTOR

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CDS, CGA, JFL, CEM, JGS, CGZ

Prescription Use : Yes

Device Count : 1

NOVA - 00385480131940 Catalog Number : 13194

Device Description : NOVA 4/12 W/R/H PUMP TUBING

Device Class : 1

Duns Number: 070617139

Premarket Exempt : No

Product Code : JIX, JFP, CDS, JGS, JJY, CEM, NDW, JFL, CGZ, CGA

Prescription Use : Yes

Device Count : 1

NOVA - 00385480131957 Catalog Number : 13195

Device Description : NOVA 1/5/11/13 WITH DILUTOR/ NOVA 8 WITH OUT DILUTOR: W/R PUMP TUBING

Device Class : 1

Duns Number: 070617139

Premarket Exempt : No

Product Code : JFP, CGZ, CHL, CFA, JPI, NDW, JGS, CEM

Prescription Use : Yes

Device Count : 1

NOVA - 00385480131964 Catalog Number : 13196

Device Description : NOVA 1/5/11/13 W/R PUMP TUBE WITHOUT DILUTOR

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CEM, CGZ, NDW, JPI, JGS

Prescription Use : Yes

Device Count : 1

NOVA - 00385480131971 Catalog Number : 13197

Device Description : NOVA 10 W/R PUMP TUBE WITH DILUTOR

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : NDW, CEM, CGZ, JGS, JFP

Prescription Use : Yes

Device Count : 1

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