Who else makes this device?

Name: Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents
Brand: Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents

Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents · Ldl & Vldl Precipitation, Cholesterol via Esterase-Oxidase, Hdl → Clinical Chemistry

2manufacturers in China registered for this device type

2catalogue numbers in this listing

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 Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents
Listed by	Siemens Healthcare Diagnostics Inc, United States
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, Complaint-file establishment, Manufacturer, Exporter
510(k)	K982341
Record published	2020-09-24
Record revised	2023-07-06 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C; Special storage condition: Do not freeze
Distribution end date	2021-11-01

Catalogue Numbers

Catalogue numbers for Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents
Catalogue number	Size	Status
10283089		In distribution
10309507		Withdrawn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
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
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

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 Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Siemens Healthcare Diagnostics Inc	510(k) number	2016-03-17	Class II	Device Design	Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn	137422 units total	2017-09-25

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.

Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents