FDA.reportPublic FDA data

Stat Profile

Primary DI
10385480616055
Brand
Stat Profile
Company
NOVA BIOMEDICAL CORPORATION
Model
Prime Plus
Catalog number
61605
Device description
Stat Profile Prime Plus MicroSensor Card™ with COOX 100
Published
2022-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GGZOXYHEMOGLOBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGZOxyhemoglobinHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480616055PackageGS11In Commercial Distribution
00385480616058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548061605510385480616055
00385480616058003854806160583854806160580385480616058

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

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
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
00385480574549Stat ProfileNOVA BIOMEDICAL CORPORATIONGGZ2022-12-08
00385480574587Stat ProfileNOVA BIOMEDICAL CORPORATIONGGZ2022-12-08
00385480596961Stat ProfileNOVA BIOMEDICAL CORPORATIONGGZ2022-12-08
00385480616058Stat Profile NOVA BIOMEDICAL CORPORATIONGGZ2022-06-16
00385480646048Stat ProfileNOVA BIOMEDICAL CORPORATIONGGZ2022-06-06
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480420174STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480420181STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485623STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485586STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485616STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485630STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485647STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485661Stat ProfileNOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485678STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485685STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485838STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485845STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485852Stat ProfileNOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485876Stat ProfileNOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485883Stat ProfileNOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485890Stat ProfileNOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480485944STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480489546Stat ProfileNOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480489553Stat ProfileNOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480492041STAT PROFILENOVA BIOMEDICAL CORPORATIONGGZ2016-09-20
00385480492058Stat ProfileNOVA BIOMEDICAL CORPORATIONGGZ2016-09-16