FDA.reportPublic FDA data

NOVA

Primary DI
00385480165013
Brand
NOVA
Company
NOVA BIOMEDICAL CORPORATION
Model
4/10/12
Catalog number
16501
Device description
NOVA 4/10/12 AIR DETECTOR
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
CDSELECTRODE, ION SPECIFIC, UREA NITROGEN
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CGAGLUCOSE OXIDASE, GLUCOSE
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
JFLPH RATE MEASUREMENT, CARBON-DIOXIDE
JFPELECTRODE, ION SPECIFIC, CALCIUM
JGSELECTRODE, ION SPECIFIC, SODIUM
NDWAssay, porphyrin, spectrophotometry, lithium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDSElectrode, Ion Specific, Urea NitrogenClinical Chemistry2
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
JFLPh Rate Measurement, Carbon-DioxideClinical Chemistry2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
NDWAssay, Porphyrin, Spectrophotometry, LithiumClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924743000NOVA 12 ANALYZER, MODIFICATIONNova Biomedical Corp.1992-11-06CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385480165013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480165013003854801650133854801650130385480165013

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 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00054749005710i-STAT G CartridgeABBOTT POINT OF CARE INC.CGA2024-04-30
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
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
10888277409187MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-11
10888277409170MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-10
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11
10054749005519i-STATABBOTT POINT OF CARE INC.CDS2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CGZ2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.JGS2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.JFL2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CGA2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.JFP2020-05-01
00024291121831On Call Express Blood Glucose Monitoring SystemNAVAJO MANUFACTURING COMPANYCGA2020-03-30
00024291121848On Call Express Blood Glucose Test StripsNAVAJO MANUFACTURING COMPANYCGA2020-03-30
00015482502300Assure® PlatinumARKRAY USA, INC.CGA2019-11-25
30804084000144IDEAL LIFE Blood Glucose Test Strips 1 vial of 25 Test StripsIdeal Life IncCGA2019-08-02
00015482512057GLUCOCARD® W Blood Glucose Test StripsARKRAY USA, INC.CGA2019-04-01
08809301160411Gmate Smart Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-09-17
08809301168011GlucoTrack Blood Glucose Test StripsPHILOSYS Co., LtdCGA2018-08-16
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
08809301168103GlucoTrack VOICE Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168110GlucoTrack SMART Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16