FDA.reportPublic FDA data

Stat Profile

Primary DI
00385480646048
Brand
Stat Profile
Company
NOVA BIOMEDICAL CORPORATION
Model
Prime Plus
Catalog number
64604
Device description
Stat Profile Prime Plus MicroSensor Card™ 100
Published
2022-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGLUCOSE OXIDASE, GLUCOSE
CHLElectrode measurement, blood-gases (pco2, po2) and blood ph
GGZOXYHEMOGLOBIN
JGSELECTRODE, ION SPECIFIC, SODIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
GGZOxyhemoglobinHematology2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480646045PackageGS11In Commercial Distribution
00385480646048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548064604510385480646045
00385480646048003854806460483854806460480385480646048

GMDN Terms#

Term, Definition table
TermDefinition
Single-channel clinical chemistry analyser IVD, point-of-careA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative determination of one or multiple clinical chemistry analytes in a clinical specimen. Analytes measured include multiple clinical chemistry analytes such as glucose, ketone, specific proteins, clinical chemistry substrates, enzymes and/or a lipid profile, using a single technology such as electrometry, spectrophotometry, fluorimetry, radiometry or chemiluminescence.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
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
05700693930978ABL90 FLEXRadiometer Medical ApSJGS2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCHL2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCGA2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSJGS2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGA2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCHL2026-07-09
05700699446572SP90Radiometer Medical ApSJGS2026-07-09
05700699446572SP90Radiometer Medical ApSCHL2026-07-09
05700699446572SP90Radiometer Medical ApSCGA2026-07-09
05700699447579SP90Radiometer Medical ApSJGS2026-07-09
05700699447579SP90Radiometer Medical ApSCGA2026-07-09
05700699447579SP90Radiometer Medical ApSCHL2026-07-09
05700699461056SC90Radiometer Medical ApSJGS2026-07-09
05700699461056SC90Radiometer Medical ApSCGA2026-07-09
05700699461056SC90Radiometer Medical ApSCHL2026-07-09
05700699461087SC90Radiometer Medical ApSCGA2026-07-09
05700699461087SC90Radiometer Medical ApSCHL2026-07-09
05700699461087SC90Radiometer Medical ApSJGS2026-07-09
05700699461094SC90Radiometer Medical ApSCHL2026-07-09
05700699461094SC90Radiometer Medical ApSJGS2026-07-09
05700699461094SC90Radiometer Medical ApSCGA2026-07-09
05700699461100SC90Radiometer Medical ApSCGA2026-07-09
05700699461100SC90Radiometer Medical ApSJGS2026-07-09
05700699461100SC90Radiometer Medical ApSCHL2026-07-09
05700699461131SC90Radiometer Medical ApSCHL2026-07-09
05700699461131SC90Radiometer Medical ApSCGA2026-07-09
05700699461131SC90Radiometer Medical ApSJGS2026-07-09
05700699461605SC90Radiometer Medical ApSCHL2026-07-09
05700699461605SC90Radiometer Medical ApSJGS2026-07-09
05700699461605SC90Radiometer Medical ApSCGA2026-07-09