FDA.reportPublic FDA data

PTS Panels® Ketones Test Strips

Primary DI
00381931718012
Brand
PTS Panels® Ketones Test Strips
Company
POLYMER TECHNOLOGY SYSTEMS, INC.
Model
1718
Catalog number
1718
Device description
PTS Panels® Ketone test strips are in vitro diagnostic devices used to monitor ketone levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.
Published
2016-09-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JMKACID, ALPHA-KETOBUTYRIC AND NADH (U.V.), HYDROXYBUTYRIC DEHYDROGENASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric DehydrogenaseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981865000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981865000MTM BIOSCANNER K TEST STRIPSPolymer Technology Systems, Inc.1999-02-26JMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00381931718012PrimaryGS10
10381931718019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381931718012003819317180123819317180120381931718012
1038193171801910381931718019

GMDN Terms#

Term, Definition table
TermDefinition
Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used together to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight Keep dry
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep away from sunlightKeep dry
Special Storage Condition, Specify00Keep dry.
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)870-5610customerservice@ptsdiagnostics.com
+1(888)877-5610customerservice@ptsdiagnostics.com
+1(877)870-5610customerservice@ptsdiagnostics.com

Regulatory Flags#

DUNS number
835772872
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00381930737014A1CNow+ Controls™ Levels 1+27377372019-11-15
00381931716018PTS Panels® Triglycerides Test Strips171617162016-07-22
00381934770017CholesterolREF 477047702025-06-16
00381934774015PTS Diagnostics Capillary TubesREF 477447742025-06-16
10381934770014CholesterolREF 477047702025-06-16
10381934774012PTS Diagnostics Capillary TubesREF 477447742025-06-16
00381933080018A1CNow Self Check, 8ct.308030802023-10-25
10381933080015A1CNow Self Check, 8ct.308030802023-10-25
00381934750019CardioChek Plus Home Self-Test Analyzer475047502022-04-11
00381934720012CardioChek Plus Home Self-Test Analyzer472047202021-02-08
00381931708013CardioChek® PA analyzer170817082016-07-15
00381931709010CardioChek® Analyzer170917092016-07-15
00381931757011CardioChek® PA Professional Analyzer, Refurbished175717572016-07-15
00381931782013CardioChek® Analyzer; Refurbished178217822016-07-15
00381932700016CardioChek® Plus Professional Analyzer270027002016-07-15
00381932701013CardioChek® Plus Professional Analyzer270127012016-07-15
00381932702010CardioChek® Plus Professional Analyzer, Refurbished270227022016-07-15
00021292015022TRUE+ A1CNow Self Check307530752023-07-30
00381932488013Assy Vial, eGLU, 13 ct.REF 2488REF 24882023-07-30
10021292015029TRUE+ A1CNow Self CheckC8H01-02C8H01-022023-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971674863397BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863403BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863410BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863427BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863434BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863441BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863458BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863465BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863472BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863489BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863496BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863502BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863519BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
05055273215571LIQUID RANBUT (RBT)RANDOX LABORATORIES LIMITEDJMK2022-09-23
05055273215588LIQUID RANBUT (RBT)RANDOX LABORATORIES LIMITEDJMK2022-09-23