FDA.reportPublic FDA data

NOVA

Primary DI
00385480152655
Brand
NOVA
Company
NOVA BIOMEDICAL CORPORATION
Model
8
Catalog number
15265
Device description
NOVA 8 IONIZED MAGNESIUM 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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CFAELECTRODE, ION SPECIFIC, MAGNESIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFAElectrode, Ion Specific, MagnesiumClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924547000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924547000NOVA 8 CRT ANALYZERNova Biomedical Corp.1993-01-28JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480152652PackageGS14In Commercial Distribution
00385480152655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548015265210385480152652
00385480152655003854801526553854801526550385480152655

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

Contacts#

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

Regulatory Flags#

DUNS number
070617139
Device count
1
Lot or batch
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
00385480118026STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-22
00385480152150NOVANOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480359429STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480374132STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480375559STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480375627STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480420174STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480420181STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480485562STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480485623STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480539913NOVANOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480539920NOVANOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480128827NOVANOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480132039NOVANOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480141826NOVANOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480142441NOVANOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480150866NOVANOVA BIOMEDICAL CORPORATIONCFA2016-09-20
10385480152652NOVANOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480230230STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480248198STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480329651STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480362597STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480364591STAT PROFILENOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480367868Stat ProfileNOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480379595Stat ProfileNOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480381857Stat ProfileNOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480407212Stat ProfileNOVA BIOMEDICAL CORPORATIONCFA2016-09-20
00385480407229Stat ProfileNOVA BIOMEDICAL CORPORATIONCFA2016-09-20