NOVA BIOMEDICAL CORPORATION

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

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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, CHLORIDE (CGZ) (8) ELECTRODE, ION SPECIFIC, SODIUM (JGS) (7) ELECTRODE, ION SPECIFIC, POTASSIUM (CEM) (7) PH RATE MEASUREMENT, CARBON-DIOXIDE (JFL) (6) Assay, porphyrin, spectrophotometry, lithium (NDW) (6) ELECTRODE, ION SPECIFIC, CALCIUM (JFP) (4) DEVICE, HEMATOCRIT MEASURING (JPI) (4) ELECTRODE, ION SPECIFIC, UREA NITROGEN (CDS) (3) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (3) GLUCOSE OXIDASE, GLUCOSE (CGA) (3) MIXTURE, HEMATOLOGY QUALITY CONTROL (JPK) (3) ANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) CLINICAL USE (JJC) (3) ELECTRODE, ION SPECIFIC, MAGNESIUM (CFA) (3) Multi-analyte controls, all kinds (assayed) (JJY) (2) ELECTRODE, ION BASED, ENZYMATIC, CREATININE (CGL) (2)

Premarket Exempt

Clear

NOVA - 00385480139861 Catalog Number : 13986

Device Description : NOVA MICROSAMPLE DILUENT

Device Class : 1

Duns Number: 070617139

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

NOVA - 00385480140621 Catalog Number : 14062

Device Description : NOVA 4/5/12/13/14 CHLORIDE SENSOR

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CGZ

Prescription Use : Yes

Device Count : 1

Nova - 00385480140713 Catalog Number : 14071

Device Description : LINEARITY STANDARD SET A

Device Class : 1

Duns Number: 070617139

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

NOVA - 00385480140829 Catalog Number : 14082

Device Description : NOVA 4 MICROSAMPLE STANDARD

Device Class :

Duns Number: 070617139

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 30

NOVA - 00385480141567 Catalog Number : 14156

Device Description : NOVA 5/5+ Analyzer w/ Printer( No Acc Pack)

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CEM, CGZ, JPI, JGS

Prescription Use : Yes

Device Count : 1

NOVA - 00385480141789 Catalog Number : 14178

Device Description : NOVA 4/10 S LINE

Device Class :

Duns Number: 070617139

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 6

NOVA - 00385480141826 Catalog Number : 14182

Device Description : Nova 1/4/5/8/10/11/12/13/14/16 Sensor Seal Kit

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : CFA, CDS, JGS, CGZ, NDW, JFL, CGA, CGL, CEM, JPI, JFP, JPK, JIX, JJC

Prescription Use : Yes

Device Count : 180

NOVA - 00385480141871 Catalog Number : 14187

Device Description : NOVA 4 TUBING HARNESS WITHOUT DILUTOR

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

NOVA - 00385480142441 Catalog Number : 14244

Device Description : NOVA 1/4/5/8/10/11/12/13/14 REFERENCE SENSOR

Device Class : 1

Duns Number: 070617139

Premarket Exempt : No

Product Code : JIX, JFL, CFA, JJC, CGZ, JPI, CEM, NDW, CDS, JGS, CGA, JFP, JPK

Prescription Use : Yes

Device Count : 1

NOVA - 00385480142533 Catalog Number : 14253

Device Description : Microsample Tube Kit 50 ul Nova CRT

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : JJC, NDW, JPK, JIX, CEM, JPI, CFA, CGL, JFL, JFP, CGA, JGS, CDS, CGZ

Prescription Use : Yes

Device Count : 100

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