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) (6) ELECTRODE, ION-SPECIFIC, CHLORIDE (CGZ) (6) ELECTRODE, ION SPECIFIC, MAGNESIUM (CFA) (6) ELECTRODE, ION SPECIFIC, POTASSIUM (CEM) (6) ELECTRODE, ION SPECIFIC, UREA NITROGEN (CDS) (6) DEVICE, HEMATOCRIT MEASURING (JPI) (6) ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH (CHL) (6) ELECTRODE, ION SPECIFIC, CALCIUM (JFP) (6) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (5) Assay, porphyrin, spectrophotometry, lithium (NDW) (4) PH RATE MEASUREMENT, CARBON-DIOXIDE (JFL) (4) Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide (JKS) (3) ANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) CLINICAL USE (JJC) (3) ELECTRODE, ION BASED, ENZYMATIC, CREATININE (CGL) (3) GLUCOSE OXIDASE, GLUCOSE (CGA) (3) MIXTURE, HEMATOLOGY QUALITY CONTROL (JPK) (3) Multi-analyte controls, all kinds (assayed) (JJY) (2) ACID, LACTIC, ENZYMATIC METHOD (KHP) (2)

Premarket Exempt

Clear

NOVA - 00385480087964 Catalog Number : 8796

Device Description : NOVA 12/14 BUN MEMBRANE KIT

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : CDS

Prescription Use : Yes

Device Count : 3

NOVA - 00385480095839 Catalog Number : 9583

Device Description : NOVA 1-16 MIXER

Device Class : 1

Duns Number: 070617139

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

STAT PROFILE - 00385480097963 Catalog Number : 9796

Device Description : STAT PROFILE ULTRA pH SEALING WASHERS

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 4

STAT PROFILE - 00385480097970 Catalog Number : 9797

Device Description : STAT PROFILE/ULTRA PCO2, SEALING WASHERS

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 4

STAT PROFILE - 00385480097987 Catalog Number : 9798

Device Description : STAT PROFILE PO2, SO2 SEALING WASHERS

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL, JKS

Prescription Use : Yes

Device Count : 8

NOVA - 00385480112727 Catalog Number : 11272

Device Description : NOVA CLEANING SOLUTION

Device Class : 1

Duns Number: 070617139

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

STAT PROFILE - 00385480115339 Catalog Number : 11533

Device Description : STAT PROFILE/M/ULTRA CAPILLARY TUBE KIT: 250uL WITH Li HEPARIN

Device Class :

Duns Number: 070617139

Premarket Exempt : No

Product Code : CEM, JFP, CGZ, CDS, JIX, KHP, JPI, JJY, JKS, JGS, CFA, CHL

Prescription Use : Yes

Device Count : 100

STAT PROFILE - 00385480118026 Catalog Number : 11802

Device Description : STAT PROFILE PREHEATER CLEANING AGENT

Device Class : 1

Duns Number: 070617139

Premarket Exempt : No

Product Code : JIX, CDS, CHL, CGZ, JGS, JFP, JKS, JPI, KHP, JJY, CFA, CEM

Prescription Use : Yes

Device Count : 1

NOVA/STAT PROFILE - 00385480127042 Catalog Number : 12704

Device Description : PREHEATER DEPROTEINIZING SOLUTION

Device Class :

Duns Number: 070617139

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 30

NOVA - 00385480128827 Catalog Number : 12882

Device Description : Nova 1/4/5/8/10/11/13 Dilutor Pack

Device Class : 1

Duns Number: 070617139

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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