Who else makes this device?

Name: L-Type HDL-C Reagent 1
Brand: L-Type HDL-C Reagent 1

Clinical Chemistry › Test SystemsLdl & Vldl Precipitation, Hdl

L-Type HDL-C Reagent 1

2 catalogue numbers from 997-72591, listed by Fujifilm Wako Pure Chemical Corporation, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

2catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (2), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LBR
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Urit Medical Electronic Co., Ltd.	Guilin	Guangxi	Contract manufacturer	28
Hangzhou Lysun Biotechnology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	22

Record

Regulatory record for L-Type HDL-C Reagent 1
Listed by	Fujifilm Wako Pure Chemical Corporation
FDA product code	LBR
Device type	Ldl & Vldl Precipitation, Hdl
Device class	Class 1
Regulation	21 CFR 862.1475
510(k)	K963847
Record published	2016-11-23
Record revised	2022-03-08 (version 6)

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	Special storage condition: Store at 2-10C. Do not freeze.
Distribution end date	2020-10-23

Catalogue Numbers

Catalogue numbers for L-Type HDL-C Reagent 1
Catalogue number	Size	Per pack	Status
997-72591		4	In distribution
997-72591		4	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pointe Scientific, Inc.	Horiba Instruments Incorporated	11
Synermed®	Infrared Laboratory Systems LLC	4
LDL-Cholesterol Gen.3	Roche Diagnostics Gmbh	3
L-Type HDL-C Reagent 2	Fujifilm Wako Pure Chemical Corporation	2
Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix	Teco Diagnostics	2
N-geneous LDL Cholesterol Reagent (R1)	Sekisui Diagnostics, LLC	2
N-geneous LDL Cholesterol Reagent (R2)	Sekisui Diagnostics, LLC	2
PTS Panels® HDL Cholesterol Test Strips	Polymer Technology Systems	2
Teco Diagnostics HDL Cholesterol Reagent Set	Teco Diagnostics	2
CardioChek	Henry Schein, Inc.	2
Carolina Liquid Chemistries Corp.® CLC720 HDL RGT KIT Product No. ST616	Carolina Liquid Chemistries	1
Curo L5	KPI Healthcare, Inc.	1

Showing 12 of 47. All products under Ldl & Vldl Precipitation, 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.