FDA.reportPublic FDA data

StatSensor StatStrip

Primary DI
00385480667685
Brand
StatSensor StatStrip
Company
NOVA BIOMEDICAL CORPORATION
Model
Gen 2.0
Catalog number
66768
Device description
StatSensor StatStrip Docking Station (Quad Bay)
Published
2026-05-06
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
PZIPrescription use blood glucose meter for near-patient testing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZIPrescription Use Blood Glucose Meter For Near-Patient TestingClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232075000StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation2024-02-23PZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385480667685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480667685003854806676853854806676850385480667685

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, point-of-careA collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Contacts#

Phone, Email table
PhoneEmail
+18005456682info@novabio.com

Regulatory Flags#

DUNS number
070617139
Device count
1
Serial number
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
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
00385480632300Nova PrimaryNova Primary Glucose Membrane 632302023-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385480657365StatSensor StatStripNOVA BIOMEDICAL CORPORATIONPZI2026-05-06
00385480667678StatSensor StatStripNOVA BIOMEDICAL CORPORATIONPZI2026-05-06
00015482600501Assure® Titanium Blood Glucose Test StripsARKRAY USA, INC.PZI2025-09-15
00015482601003Assure® Titanium Blood Glucose Test StripsARKRAY USA, INC.PZI2025-09-15
00015482600013Assure® Titanium Blood Glucose MeterARKRAY USA, INC.PZI2025-09-15
10015482600508Assure® Titanium Blood Glucose Test StripsARKRAY USA, INC.PZI2025-09-15
10015482601000Assure® Titanium Blood Glucose Test StripsARKRAY USA, INC.PZI2025-09-15
00385480636858StatStripNOVA BIOMEDICAL CORPORATIONPZI2024-03-28
00385480533980STATSTRIPNOVA BIOMEDICAL CORPORATIONPZI2016-09-20
00385480533997STATSTRIPNOVA BIOMEDICAL CORPORATIONPZI2016-09-20
00385480547901STATSTRIPNOVA BIOMEDICAL CORPORATIONPZI2016-09-16