FDA.reportPublic FDA data

STAT PROFILE

Primary DI
00385480353496
Brand
STAT PROFILE
Company
NOVA BIOMEDICAL CORPORATION
Model
PHOX BASIC
Catalog number
35349
Device description
Stat Profile PHOX BASIC Analyzer
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
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE
JPKMIXTURE, HEMATOLOGY QUALITY CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2
JPKMixture, Hematology Quality ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141907000STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET ANova Biomedical Corporation2015-05-29CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480353493PackageGS11In Commercial Distribution
00385480353496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548035349310385480353493
00385480353496003854803534963854803534960385480353496

GMDN Terms#

Term, Definition table
TermDefinition
Co-oximetry analyser IVD, point-of-careA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of oxygen saturation, haemoglobin derivatives and other calculated haemoximetry parameters in a whole blood specimen. Measurements may include haemoglobin oxygen saturation (SpO2), arterial oxygen saturation (SaO2), blood oxygen content/capacity, and haemoglobin forms such as oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify000 ft to 15000 ft
Special Storage Condition, Specify00Without Condensation
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
070617139
Device count
1
Serial number
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
Primary DIBrandCompanyProduct codePublished
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10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
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00382906643438BD Trucount™Becton, Dickinson And CompanyJPK2023-08-07
08430793040518Aptiva® Celiac Disease IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
08430793040570Aptiva® Celiac Disease IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
14987481102924Multi Calibrator LipidsFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIX2020-10-23
10054749005502i-STATABBOTT POINT OF CARE INC.CHL2020-10-05
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00816068020856Advanced Instruments GloCyte RBC & TNC Verification & Linearity KitAdvanced Instruments, LLCJPK2020-07-21
08058056680532Plasmaproteins Cal 3xSENTINEL CH. SPAJIX2018-11-15
08426950554578QUANTA Flash® PR3 CalibratorsINOVA DIAGNOSTICS, INC.JIX2017-08-28
10629009041059Visu-Cal F Frozen Calibrator PlasmaAffinity Biologicals IncJIX2017-04-28
10629009041257VisuCal-F Frozen Calibrator PlasmaAffinity Biologicals IncJIX2017-04-28
00385480183420NOVANOVA BIOMEDICAL CORPORATIONJIX2017-04-24
10815762020091Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2016-12-20
10815762020190Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2016-12-20
08426950596080QUANTA Flash® Centromere CalibratorsINOVA DIAGNOSTICS, INC.JIX2016-09-30
15099590225759AQUIOS IMMUNO-TROL CellsBECKMAN COULTER IRELAND INC.JPK2016-09-23
15099590225865AQUIOS IMMUNO-TROL Low CellsBECKMAN COULTER IRELAND INC.JPK2016-09-23
00816068020238Advanced Instruments GloCyte® Controls KitAdvanced Instruments, LLCJPK2016-09-23
00385480118026STAT PROFILENOVA BIOMEDICAL CORPORATIONCHL2016-09-22
00385480152150NOVANOVA BIOMEDICAL CORPORATIONCHL2016-09-20
00385480214902STAT PROFILENOVA BIOMEDICAL CORPORATIONJPK2016-09-20
00385480214902STAT PROFILENOVA BIOMEDICAL CORPORATIONCHL2016-09-20
00385480214902STAT PROFILENOVA BIOMEDICAL CORPORATIONJIX2016-09-20
00385480217958STAT PROFILENOVA BIOMEDICAL CORPORATIONCHL2016-09-20