FDA.reportPublic FDA data

Stat Profile

Primary DI
00385480379595
Brand
Stat Profile
Company
NOVA BIOMEDICAL CORPORATION
Model
CCX
Catalog number
37959
Device description
Stat Profile CCX Reference Sensor
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDSELECTRODE, ION SPECIFIC, UREA NITROGEN
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CFAELECTRODE, ION SPECIFIC, MAGNESIUM
CGAGLUCOSE OXIDASE, GLUCOSE
CGLELECTRODE, ION BASED, ENZYMATIC, CREATININE
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GHSASSAY, CARBOXYHEMOGLOBIN
GKRSYSTEM, HEMOGLOBIN, AUTOMATED
JFPELECTRODE, ION SPECIFIC, CALCIUM
JGSELECTRODE, ION SPECIFIC, SODIUM
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE
JJSCONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
JKSSpectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide
JPIDEVICE, HEMATOCRIT MEASURING
JPKMIXTURE, HEMATOLOGY QUALITY CONTROL
KHPACID, LACTIC, ENZYMATIC METHOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDSElectrode, Ion Specific, Urea NitrogenClinical Chemistry2
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CFAElectrode, Ion Specific, MagnesiumClinical Chemistry1
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGLElectrode, Ion Based, Enzymatic, CreatinineClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
GHSAssay, CarboxyhemoglobinHematology2
GKRSystem, Hemoglobin, AutomatedHematology2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2
JJSControls For Blood-Gases, (Assayed And Unassayed)Clinical Chemistry1
JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-MonoxideClinical Toxicology1
JPIDevice, Hematocrit MeasuringHematology2
JPKMixture, Hematology Quality ControlHematology2
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020297000STAT PROFILE CRITICAL CARE XPRESS ANALYZERNova Biomedical Corp.2002-06-10CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385480379595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480379595003854803795953854803795950385480379595

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic profile clinical chemistry analyser IVD, portable, automatedA portable mains electricity (AC-powered) laboratory instrument, typically with rechargeable batteries for power at the point-of-care in acute care settings, intended used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., Sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with minimal technician involvement and automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-6682info@novabio.com

Regulatory Flags#

DUNS number
070617139
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385480657365StatSensor StatStripGen 2.0657362026-05-06
00385480667678StatSensor StatStripGeen 2.0667672026-05-06
00385480667685StatSensor StatStripGen 2.0667682026-05-06
10385480632307Nova PrimaryNova Primary Glucose Membrane 632302023-02-22
00385480632317Nova PrimaryNova Primary Glucose Sensor 632312023-02-09
00385480533980STATSTRIP1.75533982016-09-20
00385480533997STATSTRIP1.75533992016-09-20
00385480547901STATSTRIP1.86547902016-09-16
00385480636858StatStrip63685636852024-03-28
10385480534939NOVAMAX PLUS KETONE534932016-09-20
00385480434355Nova MaxPlus434352016-09-20
00385480434362Nova MaxPlus434362016-09-20
00385480458245Nova MaxPlus458242016-09-20
20385480534936NOVAMAX PLUS KETONE534932016-09-20
10385480631645Nova PrimaryNova Primary Ampuled Control 1, 2631642023-02-24
10385480631652Nova PrimaryNova Primary Linearity Level 1 631652023-02-24
10385480631669Nova Primary Nova Primary Linearity Level 2631662023-02-24
00385480631648Nova PrimaryNova Primary Ampuled Control 1, 2631642023-02-24
00385480631655Nova PrimaryNova Primary Linearity Level 1 631652023-02-24
00385480631662Nova Primary Nova Primary Linearity Level 2631662023-02-24

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Primary DI, Brand, Company table
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08718734961093CueSee® Hyperbaric X-HighEurotrol B.V.JJS2021-06-08
08718734960652CueSee® HypoxicEurotrol B.V.JJS2020-10-08
10054749005502i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
10054749005502i-STATABBOTT POINT OF CARE INC.CHL2020-10-05
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10054749005519i-STATABBOTT POINT OF CARE INC.JFP2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.JGS2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CGZ2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CDS2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.JPI2020-05-01
08058056680532Plasmaproteins Cal 3xSENTINEL CH. SPAJIX2018-11-15
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08809301168042GlucoTrack Blood Glucose Test StripsPHILOSYS Co., LtdCGA2018-08-16
08809301168080GlucoTrack Voice Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168097GlucoTrack VOICE Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
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08809301168110GlucoTrack SMART Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
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