Who else makes this device?

Name: HDL-Cholesterol plus 3rd generation
Brand: HDL-Cholesterol plus 3rd generation

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

HDL-Cholesterol Plus 3rd Generation

Catalogue number 05401488190, 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

1catalogue number

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 plus 3rd generation
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)	K963213
Record published	2021-02-08
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

Catalogue Numbers

Catalogue numbers for HDL-Cholesterol plus 3rd generation
Catalogue number	Size	Status
05401488190		In distribution

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
HDL-Cholesterol Gen.4	Roche Diagnostics Gmbh	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

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 Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of HDL-Cholesterol plus 3rd generation
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Roche Diagnostics Operations	510(k) number	2015-05-07	Class II	Under Investigation by firm	Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or	6255 analytical units	2017-03-24

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.