Who else makes this device?

Name: Chemistry HDL Calibrator Kit
Brand: Chemistry HDL Calibrator Kit

Chemistry HDL Calibrator Kit · Calibrator, Secondary → Clinical Chemistry

1manufacturer

1catalogue number

1recall

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code JIT
Manufacturer	City	Province	Registered as	Device types
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	4

Record

Regulatory record for Chemistry HDL Calibrator Kit
Listed by	Medica Corp., United States
FDA product code	JIT
Device type	Calibrator, Secondary
Device class	Class 2
Regulation	21 CFR 862.1150
Establishment	Repacker / relabeller, Manufacturer
510(k)	K073497
Record published	2019-02-14
Record revised	2022-03-08 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Chemistry HDL Calibrator Kit
Catalogue number	Size	Status
10653		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Vitros	Ortho-Clinical Diagnostics, Inc.	39
Exact Diagnostics	Exact Diagnostics	30
Architect	Abbott Medical	26
Architect	Abbott Ireland	24
Alinity	Abbott Medical	18
Alinity	Abbott Ireland	16
Architect	Abbott Laboratories	15
Architect	Abbott Ireland Diagnostics	11
Alinity	Abbott Ireland Diagnostics	11
JAS Diagnostics	Drew Scientific, Ltd.	10
BioPlex 2200	Bio-Rad Laboratories Inc.	8
AU	Beckman Coulter, Inc.	6

Showing 12 of 391. All products under Calibrator, Secondary

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	Closed
2017-04-11	Class II	Process design	Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.	2019-08-20

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.

Chemistry HDL Calibrator Kit