Who else makes this device?

Name: LD opt. (LDH P-L)
Brand: LD opt. (LDH P-L)

Clinical Chemistry › Test SystemsNad Reduction/Nadh Oxidation, Lactate Dehydrogenase

LD Opt. (LDH P-L)

2 catalogue numbers from LD8051, listed by Randox Laboratories Limited, United Kingdom, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

2recalls on this code

Who Else Makes It

Concentrated in Jilin (1), Shandong (1).

Chinese manufacturers registered for FDA product code CFJ
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70

Record

Regulatory record for LD opt. (LDH P-L)
Listed by	Randox Laboratories Limited, United Kingdom
FDA product code	CFJ
Device type	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device class	Class 2
Regulation	21 CFR 862.1440
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2019-06-03
Record revised	2023-07-06 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for LD opt. (LDH P-L)
Catalogue number	Size	Status
LD8051		In distribution
LD8322		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Biobase	Biobase Biodustry(Shandong)Co., Ltd.	13
Pointe Scientific, Inc.	Horiba Instruments Incorporated	10
JAS Diagnostics	Drew Scientific, Ltd.	8
Synermed®	Infrared Laboratory Systems LLC	7
Synchron	Beckman Coulter, Inc.	4
Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix	Teco Diagnostics	3
Lactate dehydrogenase liquid acc to Ifcc	Roche Diagnostics Gmbh	3
Alinity	Abbott Ireland	2
LDH L-P	Randox Laboratories Limited	2
Lactate Dehydrogenase acc. to Ifcc ver.2	Roche Diagnostics Gmbh	2
LDH P-L	Randox Laboratories Limited	2
Architect	Abbott Medical	2

Showing 12 of 60. All products under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K970684	1997-05-07

Recalls

2 of these are 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
2020-08-11	Class II	Under Investigation by firm	An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the t	4	2020-10-15
2020-08-11	Class II	Under Investigation by firm	An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the t	21	2020-10-15

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.