FDA.reportPublic FDA data

NOVA

Primary DI
10385480152126
Brand
NOVA
Company
NOVA BIOMEDICAL CORPORATION
Model
10
Catalog number
15212
Device description
NOVA 10/10+ Analyzer w Printer (w Acc Pack)
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDWAssay, porphyrin, spectrophotometry, lithium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDWAssay, Porphyrin, Spectrophotometry, LithiumClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923806000ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATERNova Biomedical Corp.1992-09-29JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480152126PackageGS11In Commercial Distribution
00385480152129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548015212610385480152126
00385480152129003854801521293854801521290385480152129

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
Special Storage Condition, Specify000 ft to 6500 ft
Special Storage Condition, Specify00Without Condensation
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
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
false
Serial number
true
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 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
00811403010691Lithium ElectrodeDiamond Diagnostics Inc.NDW2023-06-05
00630414287935Atellica CH Lithium_2 (LITH_2)Siemens Healthcare Diagnostics Inc.NDW2020-11-27
00630414288178ADVIA Chemistry Lithium_2 (LITH_2) reagentsSiemens Healthcare Diagnostics Inc.NDW2020-11-27
07613336121382LithiumRoche Diagnostics GmbHNDW2020-03-05
00380740136277AlinityABBOTT LABORATORIESNDW2018-07-30
00630414006789Atellica CH LiSiemens Healthcare Diagnostics Inc.NDW2017-12-21
00385480167291NOVANOVA BIOMEDICAL CORPORATIONNDW2017-04-24
00842768035326Dimension Vista® Flex® reagent cartridge LITHSiemens Healthcare Diagnostics Inc.NDW2016-09-24
00630414509778ADVIA® Chemistry LITH Lithium ReagentsSiemens Healthcare Diagnostics Inc.NDW2016-09-24
00385480152112NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480152129NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480157421NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480539630NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480539647NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
04015630921669LithiumRoche Diagnostics GmbHNDW2016-09-20
04015630032440Lithium ElectrodeRoche Diagnostics GmbHNDW2016-09-20
00385480128827NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480131940NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480132039NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480136839NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480139847NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480140829NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
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00385480142441NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
10385480157428NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480165013NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480167284NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
05055273209143Li 2RANDOX LABORATORIES LIMITEDNDW2016-09-16
00845275000429Thermo Scientific Infinity™Fisher DiagnosticsNDW2016-09-16