FDA.reportPublic FDA data

STATSENSOR

Primary DI
10385480528006
Brand
STATSENSOR
Company
NOVA BIOMEDICAL CORPORATION
Model
1.0
Catalog number
52800
Device description
StatSensor Creat Test Strips
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGLELECTRODE, ION BASED, ENZYMATIC, CREATININE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGLElectrode, Ion Based, Enzymatic, CreatinineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070068000NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPSNova Biomedical Corp.2007-05-07CGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20385480528003PackageGS12In Commercial Distribution
10385480528006PrimaryGS10
00385480528009Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2038548052800320385480528003
1038548052800610385480528006
00385480528009003854805280093854805280090385480528009

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
070617139
Device count
10
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
10054749005519i-STATABBOTT POINT OF CARE INC.CGL2020-05-01
05700699441362S8377 REF 944-136 *6 Cleaning solution Met II SolutionRadiometer Medical ApSCGL2018-09-21
05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSCGL2018-09-21
05700699439062S5362 REF 943-906Radiometer Medical ApSCGL2018-09-21
05700699441263Cleaning Solution with additive S8375 REF 944-126Radiometer Medical ApSCGL2018-09-21
05700699441300Rinse Solution S4980 REF 944-130Radiometer Medical ApSCGL2018-09-21
05700699441553Rinse Solution II S4987 REF 944-155 600mLRadiometer Medical ApSCGL2018-09-21
00385480183420NOVANOVA BIOMEDICAL CORPORATIONCGL2017-04-24
10385480433706STATSENSORNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480282413NOVANOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480359429STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480374132STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480375559STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480375627STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480420174STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480420181STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480422253StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480438063StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480440523StatSensorNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480453356StatSensorNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480485623STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480486293StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480486309StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480506687StatSensorNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480517560StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480519946StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480519953StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480519960StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20