Is this your brand? Sign in to claim ownership.

Polymer Technology Systems

Last updated September 17, 2026

Information

Country: US
Address: 4600 Anson Boulevard, Whitestown, IN, 46075
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3002698769
DUNS Number: —

Catalogue (89)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
CardioChek® Plus Professional Analyzer, Refurbished	2702	FDA UDI	Class I	Active
pts collect™ Capillary Tubes	2874	FDA UDI	Class I	Active
A1CNow® Self Check Test System	3070	FDA UDI	Class II	Active
CardioChek Plus Home Lipid Panel Self-Test Strip 2ct	4722	FDA UDI	Class I	Active
CardioChek® Plus Professional Analyzer	2700	FDA UDI	Class I	Active
CardioChek® Analyzer; Refurbished	1782	FDA UDI	Class I	Active
pts collect™ Capillary Tubes	2864	FDA UDI	Class I	Unknown
CardioChek® Plus Professional Analyzer	2701	FDA UDI	Class II	Active
PTS Panels® CHOL+Glu Test Strips	1765	FDA UDI	Class I	Active
TRUE+ A1CNow Self Check	3075	FDA UDI	Class II	Active
PTS Panels® HDL Cholesterol Test Strips	1714	FDA UDI	Class I	Unknown
PTS Panels® CHOL+HDL+GLU Test Strips (10-ct) + MeMoChip	2477	FDA UDI	Class I	Active
PTS Panels Metabolic ChemistryTest Strips (15-ct)	2400	FDA UDI	Class I	Unknown
PTS Panels eGLU™ Glucose Test Strips (12-ct)	2471	FDA UDI	Class II	Active
Lipid Panel, 15ct., CCPlus Home	REF 4753	FDA UDI	Class I	Active
PTS Panels® HDL Cholesterol Test Strips	1788	FDA UDI	Class I	Active
Assy Vial, eGLU Test Strips, 1 ct, CardioChek Plus Home	4751	FDA UDI	Class II	Active
pts collect™ Capillary Tubes	2865	FDA UDI	Class I	Active
A1CNow®+ Multi-Use Test System (10 count)	3024	FDA UDI	Class II	Active
PTS Panels® CHOL+HDL+GLU Test Strips	2412	FDA UDI	Class II	Active
PTS Panels® Lipid Panel Test Strips	1710	FDA UDI	Class I	Active
Assy Vial, eGLU Test Strips, 15 ct, CardioChek Plus Home	REF 4748	FDA UDI	Class II	Active
PTS Panels® Lipid Panel Test Strips (10-ct)	2470	FDA UDI	Class I	Active
PTS Panels® Creatinine Test Strips	1720	FDA UDI	Class II	Unknown
PTS Detect® Cotinine System	3061	FDA UDI	Class I	Unknown
Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus Home	REF 4749	FDA UDI	Class I	Active
PTS Panels® Cholesterol Test Strips	1711	FDA UDI	Class I	Active
Cholesterol	REF 4770	FDA UDI	Class I	Active
pts collect™ Capillary Tubes	2134	FDA UDI	Class I	Unknown
PTS Panels eGLU™ Test Strips	2728	FDA UDI	Class II	Active
CardioChek Plus Home eGLU Self-Test Strips	4723	FDA UDI	Class II	Active
A1CNow®+ Multi-UseTest System (20 count)	3021	FDA UDI	Class II	Active
PTS Panels® CHOL+HDL Test Strips	1821	FDA UDI	Class I	Active
Assy Vial, eGLU, 13 ct.	REF 2488	FDA UDI	Class II	Active
pts panels® Multi-Chemistry Controls	721	FDA UDI	Class I	Active
A1CNow Self Check, 8ct.	3080	FDA UDI	Class II	Active
A1CNow® Self Check Test System	3030	FDA UDI	Class II	Unknown
Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk)	REF 4752	FDA UDI	Class II	Active
CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk)	2478	FDA UDI	Class II	Active
PTS Diagnostics Capillary Tubes	REF 4774	FDA UDI	Class I	Active
pts collect™ Capillary Tubes	2866	FDA UDI	Class I	Active
PTS Panels® Triglycerides Test Strips	1716	FDA UDI	Class I	Active
ChekMate™ Strips	860	FDA UDI	Class I	Unknown
CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct	4721	FDA UDI	Class II	Active
PTS Panels® CHOL+HDL+GLU Test Strips (10-ct)	2469	FDA UDI	Class I	Active
CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk)	2729	FDA UDI	Class II	Active
eGLU, 15ct., CCPlus Home	REF 4755	FDA UDI	Class II	Active
PTS Panels eGLU™ Glucose Test Strips (50-ct)	2713	FDA UDI	Class II	Active
PTS Panels® Triglycerides Test Strips	1789	FDA UDI	Class I	Active
PTS Panels® Cholesterol Test Strips	1790	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (25)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 21, 2020	Z-1438-2020	—	terminated	The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Dec 2, 2019	Z-0834-2020	—	terminated	One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Dec 2, 2019	Z-0833-2020	—	terminated	One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Dec 2, 2019	Z-0835-2020	—	terminated	One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Dec 2, 2019	Z-0832-2020	—	terminated	One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Jun 7, 2019	Z-2157-2019	—	terminated	The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Jun 7, 2019	Z-2158-2019	—	terminated	The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Jan 16, 2019	Z-1372-2019	—	terminated	Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Jan 16, 2019	Z-1371-2019	—	terminated	Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed.
Jan 16, 2019	Z-1373-2019	—	terminated	Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed
Mar 14, 2018	Z-1543-2018	—	terminated	Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
Dec 2, 2016	Z-0683-2020	—	terminated	A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Dec 2, 2016	Z-0685-2020	—	terminated	A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Dec 2, 2016	Z-0682-2020	—	terminated	A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Dec 2, 2016	Z-0684-2020	—	terminated	A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Dec 2, 2016	Z-0686-2020	—	terminated	A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Mar 15, 2016	Z-0741-2020	—	terminated	This lot of test strips is showing an under-recovery when tested against a reference method.
Apr 4, 2013	Z-1403-2013	—	terminated	Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
May 15, 2012	Z-1903-2012	—	terminated	During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay.
Jul 6, 2010	Z-2641-2010	—	terminated	The test strips appear to under-recover Cholesterol, HDL and glucose.
Aug 4, 2009	Z-1012-2010	—	terminated	Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a loss of activity. A loss of recoverable Glucose measurement is a moderate to high risk, based upon the degree of under-recovery, and the frequency of occurrence.
Jun 5, 2009	Z-1136-2010	—	terminated	Exhibits under-recovery of all analytes.
Apr 2, 2009	Z-0871-2010	—	terminated	The memory chip was coded with incorrect product information.
Feb 20, 2009	Z-0975-2010	—	terminated	Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date.
May 29, 2008	Z-1132-2010	—	terminated	The expiration date was extended by 20 weeks without justification.