Who else makes this device?

Name: NMR Reference Standard
Brand: NMR Reference Standard

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

NMR Reference Standard

NMR Reference Standard used for the Vantera Clinical Analyzer.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

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 NMR Reference Standard
Listed by	Labcorp of America
FDA product code	LBS
Device type	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Device class	Class 1
Regulation	21 CFR 862.1475
Record published	2017-04-18
Record revised	2019-09-25 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Distribution end date	2019-09-19

Catalogue Numbers

Catalogue numbers for NMR Reference Standard
Catalogue number	Size	Status
9930030		Withdrawn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
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

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.