Who else makes this device?

Name: HDL-Cholesterol Gen.4
Brand: HDL-Cholesterol Gen.4

Clinical Chemistry › Test SystemsLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

HDL-Cholesterol Gen.4

4 catalogue numbers from 08057877190, listed by Roche Diagnostics Gmbh, Germany, under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

4catalogue numbers in this listing

2510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Guangdong (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LBS
Manufacturer	City	Province	Registered as	Device types
Dongguan BAO Kang Dian ZI KE JI Limited	Dongguan	Guangdong	Contract manufacturer	24
Shijiazhuang Hipro Biotechnology Co., Ltd.	Shijiazhuang	Hebei	Manufacturer	22

Record

Regulatory record for HDL-Cholesterol Gen.4
Listed by	Roche Diagnostics Gmbh, Germany
FDA product code	LBS
Device type	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Device class	Class 1
Regulation	21 CFR 862.1475
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K162593
Record published	2020-03-05
Record revised	2023-07-06 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C
Distribution end date	2018-12-18

Catalogue Numbers

Catalogue numbers for HDL-Cholesterol Gen.4
Catalogue number	Size	Status
08057877190		In distribution
07528566190		In distribution
07528582190		In distribution
07528604190		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
JAS Diagnostics	Drew Scientific, Ltd.	6
Direct HDL-Cholesterol (HDL)	Randox Laboratories Limited	4
Synermed®	Infrared Laboratory Systems LLC	4
AU	Beckman Coulter, Inc.	4
Direct HDL Cholesterol LiquiColor®	Stanbio Laboratory, L.P.	3
Ultra N-geneous HDL Cholesterol Reagent	Sekisui Diagnostics, LLC	2
Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents	Siemens Healthcare Diagnostics Inc	2
Vitros	Ortho-Clinical Diagnostics, Inc.	2
Alinity	Abbott Medical	2
ox-LDL Elisa	Immundiagnostik, Inc.	2
ACE	Alfa Wassermann	2
HDL Ultra Cholesterol	Sekisui Diagnostics, LLC	2

Showing 12 of 30. All products under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K033610	2003-12-05
K012286	2001-08-08

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2008-06-11	Not classified	Labeling Change Control	Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.	1245	2009-09-22

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.