FDA.reportPublic FDA data

STAT PROFILE

Primary DI
10385480552636
Brand
STAT PROFILE
Company
NOVA BIOMEDICAL CORPORATION
Model
PRIME CCS
Catalog number
55263
Device description
Prime Sensor Card CCS (High Volume)
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
GKFINSTRUMENT, HEMATOCRIT, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKFInstrument, Hematocrit, AutomatedHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141907000STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET ANova Biomedical Corporation2015-05-29CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480552636PackageGS11In Commercial Distribution
00385480552639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548055263610385480552636
00385480552639003854805526393854805526390385480552639

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 Temperature2 Degrees Celsius8 Degrees Celsius
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

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00386100002664Reagent ModuleMEDICA CORPORATIONGKF2018-12-05
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONGKF2018-12-05
00386100003739pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONGKF2018-12-05
00386100002398Daily Cleaning Solution Kit MEDICA CORPORATIONGKF2018-12-04
05700699055903Disposable Waste Container D512 REF 905-590Radiometer Medical ApSGKF2018-09-21
05700699440570S4970 Rinse 1 Solution for 600mL, for ABL7xxRadiometer Medical ApSGKF2018-09-21
05700699441232Cleaning Solution with additive S7375 REF 944-123Radiometer Medical ApSGKF2018-09-21
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00831829000014UltraCritSEPARATION TECHNOLOGY, INC.GKF2017-08-25
00831829000021UltraCrit Cuvettes SEPARATION TECHNOLOGY, INC.GKF2017-08-25
00831829000045UltraCrit QC Cuvettes SEPARATION TECHNOLOGY, INC.GKF2017-08-25
00831829000069UltraChek Reference Controls Low SEPARATION TECHNOLOGY, INC.GKF2017-08-25
00831829000083UltraChek Reference Controls NormalSEPARATION TECHNOLOGY, INC.GKF2017-08-25
00831829000106UltraChek Reference Controls HighSEPARATION TECHNOLOGY, INC.GKF2017-08-25
00385480528566STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
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00385480534185STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
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00385480536561STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
00385480536578STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
00385480536660STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
00385480536677STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
00630414566788RAPIDPOINT® 340/350 Valve ModuleSiemens Healthcare Diagnostics Inc.GKF2017-03-24
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00630414443492RAPIDPoint® 400 Measurement CartridgeSiemens Healthcare Diagnostics Inc.GKF2016-09-24