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) (5) ELECTRODE, ION SPECIFIC, POTASSIUM (CEM) (5) ELECTRODE, ION-SPECIFIC, CHLORIDE (CGZ) (4) Assay, porphyrin, spectrophotometry, lithium (NDW) (4) DEVICE, HEMATOCRIT MEASURING (JPI) (3) Multi-analyte controls, all kinds (assayed) (JJY) (3) ELECTRODE, ION SPECIFIC, CALCIUM (JFP) (3) ELECTRODE, ION SPECIFIC, MAGNESIUM (CFA) (2) GLUCOSE OXIDASE, GLUCOSE (CGA) (2) PH RATE MEASUREMENT, CARBON-DIOXIDE (JFL) (1) ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH (CHL) (1) ELECTRODE, ION SPECIFIC, UREA NITROGEN (CDS) (1) ACID, LACTIC, ENZYMATIC METHOD (KHP) (1)

Premarket Exempt

Clear

NOVA - 00385480131988 Catalog Number : 13198

Device Description : NOVA 10 W/R PUMP TUBE WITHOUT DILUTOR

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

NOVA - 00385480132039 Catalog Number : 13203

Device Description : NOVA 1/5/8/10/11/13/14 SENSOR SPACER

Device Class : 1

Duns Number: 070617139

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Nova - 00385480132114 Catalog Number : 13211

Device Description : NOVA 1/1+ Analyzer w/ Printer (No Acc Pack)

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : JGS, CEM, JPI

Prescription Use : Yes

Device Count : 1

NOVA - 00385480132947 Catalog Number : 13294

Device Description : Mg+ INTERNAL FILING SOLUTION

Device Class : 1

Duns Number: 070617139

Premarket Exempt : No

Product Code : CFA

Prescription Use : Yes

Device Count : 1

NOVA - 00385480134095 Catalog Number : 13409

Device Description : NOVA GLU/LAC SENSOR SOAKING SOLUTION

Device Class : 1

Duns Number: 070617139

Premarket Exempt : No

Product Code : CGA, KHP

Prescription Use : Yes

Device Count : 1

NOVA - 00385480135238 Catalog Number : 13523

Device Description : LINEARITY STANDARD SET D

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 20

NOVA - 00385480135245 Catalog Number : 13524

Device Description : LINEARITY STANDARD SET D

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 20

NOVA - 00385480136839 Catalog Number : 13683

Device Description : NOVA 4 TUBING HARNESS WITH DILUTOR

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

NOVA - 00385480139847 Catalog Number : 13984

Device Description : NOVA 1/5/10/11/13 MICROSAMPLE STANDARD

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

NOVA - 00385480139854 Catalog Number : 13985

Device Description : NOVA 12 MICROSAMPLE STANDARD

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 30

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