Who else makes this device?

Name: Advia® Chemistry Direct LDL Cholesterol Reagents
Brand: Advia® Chemistry Direct LDL Cholesterol Reagents

Advia® Chemistry Direct LDL Cholesterol Reagents · System, Test, Low Density, Lipoprotein → Clinical Chemistry

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

2recalls on this code

Who Else Makes It

Concentrated in Shandong (1), Guangxi (1), Hebei (1).

Chinese manufacturers registered for FDA product code MRR
Manufacturer	City	Province	Registered as	Device types
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70
Urit Medical Electronic Co., Ltd.	Guilin	Guangxi	Contract manufacturer	28
Shijiazhuang Hipro Biotechnology Co., Ltd.	Shijiazhuang	Hebei	Manufacturer	22

Record

Regulatory record for Advia® Chemistry Direct LDL Cholesterol Reagents
Listed by	Siemens Healthcare Diagnostics Inc, United States
FDA product code	MRR
Device type	System, Test, Low Density, Lipoprotein
Device class	Class 1
Regulation	21 CFR 862.1475
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K982529
Record published	2020-09-24
Record revised	2023-07-06 (version 3)

Specifications

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

Catalogue Numbers

Catalogue numbers for Advia® Chemistry Direct LDL Cholesterol Reagents
Catalogue number	Size	Status
10311891		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Biobase	Biobase Biodustry(Shandong)Co., Ltd.	19
Carolina Liquid Chemistries Corp.® LDL Cholesterol Direct Reagent KIT DT661	Carolina Liquid Chemistries	4
Pointe Scientific, Inc.	Horiba Instruments Incorporated	3
Direct LDL-Cholesterol (LDL)	Randox Laboratories Limited	3
Pointe autoLDL Cholesterol Reagent	Horiba Instruments Incorporated	2
N-geneous LDL-ST Cholesterol Reagent (R1)	Sekisui Diagnostics, LLC	2
Mercodia Oxidized LDL Elisa	Mercodia AB	2
ACE	Alfa Wassermann	2
N-geneous LDL-ST Cholesterol Reagent (R2)	Sekisui Diagnostics, LLC	2
MedTest Dx, Inc. autoLDL	Medtest DX	1
Pointe Scientific, Inc. autoLDL Cholesterol	Horiba Instruments Incorporated	1
Dimension® Flex® reagent cartridge Aldl	Siemens Healthcare Diagnostics Inc	1

Showing 12 of 26. All products under System, Test, Low Density, Lipoprotein

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K241800	2024-07-26

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 Direct LDL Cholesterol Reagents
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Siemens Healthcare Diagnostics Inc	510(k) number	2023-01-27	Class II	Under Investigation by firm	Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results	8420 units

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 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
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 Direct LDL Cholesterol Reagents