FDA.reportPublic FDA data

StatStrip

Primary DI
00385480636858
Brand
StatStrip
Company
NOVA BIOMEDICAL CORPORATION
Model
63685
Catalog number
63685
Device description
StatStrip Glucose Hospital Meter System
Published
2024-03-28
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
00385480636858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480636858003854806368583854806368580385480636858

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Altitude: Up to 15,000 feet
Special Storage Condition, Specify00Relative Humidity: Up to 90% (noncondensing)

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
070617139
Device count
1
Serial number
true
Manufacturing 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
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
00385480667685StatSensor 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
00385480533980STATSTRIPNOVA BIOMEDICAL CORPORATIONPZI2016-09-20
00385480533997STATSTRIPNOVA BIOMEDICAL CORPORATIONPZI2016-09-20
00385480547901STATSTRIPNOVA BIOMEDICAL CORPORATIONPZI2016-09-16