FDA.reportPublic FDA data

pts panels® HDL Cholesterol Controls

Primary DI
00381930722010
Brand
pts panels® HDL Cholesterol Controls
Company
POLYMER TECHNOLOGY SYSTEMS, INC.
Model
722
Catalog number
722
Device description
PTS PANELS® HDL Cholesterol Controls contain cholesterol. The analyte(s) in each solution react with test strips to produce a color. The darker the color is, the higher the analyte concentration. The result for each level of control should be in the range specified on the Quality Control Range Card included with each set of controls. Controls should be run to verify the test system performance, when results are questionable, or to comply with your facility’s quality control requirements.
Published
2018-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJYMulti-analyte controls, all kinds (assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022401000PTS PANELS MULTI-CHEMISTRY CONTROLSPolymer Technology Systems, Inc.2002-08-21JJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00381930722010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381930722010003819307220103819307220100381930722010

GMDN Terms#

Term, Definition table
TermDefinition
High-density lipoprotein (HDL) cholesterol IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of high-density lipoprotein (HDL) cholesterol lipid in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze.
Special Storage Condition, Specify00Do not use beyond the expiration date on the vial.
Special Storage Condition, Specify00Opened product is stable for at least ten months at room temperature.
Special Storage Condition, Specify00Product is ready to use and is clear.
Special Storage Condition, Specify00Recap after using.
Special Storage Condition, Specify00Use care not to contaminate dropper tip.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature35 Degrees Fahrenheit46 Degrees Fahrenheit
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

Regulatory Flags#

DUNS number
835772872
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10381932488010Assy Vial, eGLU, 13 ct.REF 2488REF 24882023-07-30

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Primary DI, Brand, Company table
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05391523442848Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
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05391523442862Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442879Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442930Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
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00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
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00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
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00850011135822VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
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