FDA.reportPublic FDA data

STAT PROFILE

Primary DI
00385480498487
Brand
STAT PROFILE
Company
NOVA BIOMEDICAL CORPORATION
Model
PHOX PLUS
Catalog number
49848
Device description
Stat Profile pHOx Plus Air Detector
Published
2016-09-16
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
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CGAGLUCOSE OXIDASE, GLUCOSE
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GJSTEST, TIME, PROTHROMBIN
GKRSYSTEM, HEMOGLOBIN, AUTOMATED
JFPELECTRODE, ION SPECIFIC, CALCIUM
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE
JPIDEVICE, HEMATOCRIT MEASURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
GJSTest, Time, ProthrombinHematology2
GKRSystem, Hemoglobin, AutomatedHematology2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2
JPIDevice, Hematocrit MeasuringHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002613000MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZERNova Biomedical Corp.2000-10-19CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385480498487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480498487003854804984873854804984870385480498487

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic profile clinical chemistry analyser IVD, portable, semi-automatedA portable mains electricity (AC-powered) laboratory instrument, which may include internal rechargeable batteries, intended to be 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 in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with reduced technician involvement and automation of some procedural steps.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436540291141microINR® Expert KitILINE MICROSYSTEMS SLGJS2026-04-22
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
09360136000079 Xprecia Prime™ Coagulation AnalyzerUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
08436540291134microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
10758750031658VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CGZ2023-04-28
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
17311091118148HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-10-28
17311091118124HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-08-30
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
08430793040518Aptiva® Celiac Disease IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
08430793040570Aptiva® Celiac Disease IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
08436540290717microINR ® CHIPS ILINE MICROSYSTEMS SLGJS2021-05-28
08436540290816microINR ® MeterILINE MICROSYSTEMS SLGJS2021-05-28
14048534001967DiaSpect Tm CuvettesEKF-diagnostic GmbHGKR2021-03-11
10888277409187MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-11
10888277409170MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-10
14987481102924Multi Calibrator LipidsFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIX2020-10-23
10054749005502i-STATABBOTT POINT OF CARE INC.CHL2020-10-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11
17311091118094HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2020-09-04
10054749005519i-STATABBOTT POINT OF CARE INC.JFP2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CGZ2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CGA2020-05-01