Who else makes this device?

Name: PTS Panels® HDL Cholesterol Test Strips
Brand: PTS Panels® HDL Cholesterol Test Strips

Clinical Chemistry › Test SystemsLdl & Vldl Precipitation, Hdl

PTS Panels® HDL Cholesterol Test Strips

PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to monitor HDL cholesterol levels in human whole blood. These test strips must be used in conjunction with a…

Registry build 21.09.26

PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to monitor HDL cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.

3manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (2), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LBR
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Urit Medical Electronic Co., Ltd.	Guilin	Guangxi	Contract manufacturer	28
Hangzhou Lysun Biotechnology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	22

Record

Regulatory record for PTS Panels® HDL Cholesterol Test Strips
Listed by	Polymer Technology Systems, United States
FDA product code	LBR
Device type	Ldl & Vldl Precipitation, Hdl
Device class	Class 1
Regulation	21 CFR 862.1475
Establishment	Complaint-file establishment, Manufacturer
510(k)	K060617
Record published	2016-07-22
Record revised	2023-07-31 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Over the counter	Yes
Label carries	lot or batch number, expiry date
Storage	Special storage condition: Keep away from sunlight Keep dry; Storage environment temperature 68 to 86 °F; Storage environment temperature 20 to 30 °C
Distribution end date	2023-01-20

Catalogue Numbers

Catalogue numbers for PTS Panels® HDL Cholesterol Test Strips
Catalogue number	Size	Per pack	Status
1788		3	In distribution
1714		25	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pointe Scientific, Inc.	Horiba Instruments Incorporated	11
Synermed®	Infrared Laboratory Systems LLC	4
LDL-Cholesterol Gen.3	Roche Diagnostics Gmbh	3
L-Type HDL-C Reagent 2	Fujifilm Wako Pure Chemical Corporation	2
Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix	Teco Diagnostics	2
N-geneous LDL Cholesterol Reagent (R1)	Sekisui Diagnostics, LLC	2
N-geneous LDL Cholesterol Reagent (R2)	Sekisui Diagnostics, LLC	2
Teco Diagnostics HDL Cholesterol Reagent Set	Teco Diagnostics	2
CardioChek	Henry Schein, Inc.	2
L-Type HDL-C Reagent 1	Fujifilm Wako Pure Chemical Corporation	2
Carolina Liquid Chemistries Corp.® CLC720 HDL RGT KIT Product No. ST616	Carolina Liquid Chemistries	1
Curo L5	KPI Healthcare, Inc.	1

Showing 12 of 47. All products under Ldl & Vldl Precipitation, Hdl

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K990247	1999-05-28

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.