FDA.reportPublic FDA data

NOVA

Primary DI
10385480152652
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
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
false
Expiration date on label
false
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 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
00385480152655NOVANOVA 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
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