FDA.report

NOVA

Primary DI
00385480142441
Brand
NOVA
Company
NOVA BIOMEDICAL CORPORATION
Model
1/4/5/8/10/11/12/13/14
Catalog number
14244
Device description
NOVA 1/4/5/8/10/11/12/13/14 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
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE

Product Code Classifications

CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00385480142441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480142441003854801424413854801424410385480142441

GMDN Terms

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

TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)545-6682info@novabio.com

Regulatory Flags

DUNS number
070617139
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00385480636858StatStrip63685636852024-03-28
20385480534936NOVAMAX PLUS KETONE534932016-09-20
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
00385480632300Nova PrimaryNova Primary Glucose Membrane 632302023-02-22
00385480631679Nova PrimaryNova Primary Calibrator Cartridge 150 Sample 631672023-02-09
00385480632317Nova PrimaryNova Primary Glucose Sensor 632312023-02-09
00385480631624Nova PrimaryNova Primary Calibrator Cartridge 450 Sample 631622023-02-08
10385480634578Nova PrimaryNova Primary Analyzer634572023-02-08
00385489038738NovaNova38732022-12-07
00385489388468NovaNova388462022-12-07
00385489388833NovaNova388832022-12-07
00385489400894NovaNova400892022-12-07
00385489485907NovaNova485902022-12-07
00385480616218Stat ProfilePrime Plus616212022-12-07
00385480634120NovaNova634122022-12-07
10385480616055Stat Profile Prime Plus 616052022-06-16
10385480642511Stat ProfilePrime 642512022-04-27
10385480646045Stat ProfilePrime Plus 646042022-04-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10673486014013Teco Diagnostics Chemistry CalibratorTECO DIAGNOSTICSJIX2026-03-20
03701700817802ELICAL 2 VITALSCIENTIFICJIX2026-03-04
05430003908648SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908655SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908662SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908679SEEKER®Lacar MDX TechnologiesJIX2026-01-15
04250317554994Plasma Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2025-07-31
07613336232156Ionify CalSet Steroids and Vitamin DRoche Diagnostics GmbHJIX2025-06-25
00850053916267IDG/SanzayIDG/SANZAY CorporationJIX2024-07-03
08430793040761Aptiva® APS IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
08430793040907Aptiva® APS IgM CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
00630414304915Atellica CH Prot2 CALSiemens Healthcare Diagnostics Inc.JIX2024-02-02
04580262010314Calibrator 2TOKYO BOEKI MEDISYS INC.JIX2023-12-18
08430793040181Aptiva® CTD Essential CalibratorsINOVA DIAGNOSTICS, INC.JIX2023-12-14
00816776020544MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020568MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020582MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020599MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
10852676007060Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2023-08-09
00811403011087CO2 Alkaline BufferDiamond Diagnostics Inc.JIX2023-06-05
00816776020247MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-12-22
00817302024494CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 1 DT908CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00817302024500CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 2 DT909CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00817302024517CAROLINA LIQUID CHEMISTRIES CORP.® ISE SELECTIVITY CHECK DT910CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00380740164973ARCHITECTABBOTT IRELANDJIX2022-07-12
00380740164980AlinityABBOTT IRELANDJIX2022-07-12
04250317551115Urine Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2022-07-08
04250317552365Saliva Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2022-06-21
00816776020513MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-04-05
00816776020537MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-04-05