Who else makes this device?

Name: Diazyme
Brand: Diazyme

Clinical Chemistry › Test SystemsCalibrator, Secondary

Diazyme

5 catalogue numbers from 100148B-CAL, listed by Diazyme Laboratories, Inc., United States, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

5catalogue numbers in this listing

2510(k) clearances naming this product code

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 Diazyme
Listed by	Diazyme Laboratories, Inc., United States
FDA product code	JIT
Device type	Calibrator, Secondary
Device class	Class 2
Regulation	21 CFR 862.1150
Establishment	Specification developer, Repacker / relabeller, Manufacturer
510(k)	K141575
Record published	2026-01-21
Record revised	2026-01-29 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for Diazyme
Catalogue number	Size	Status
100148B-CAL		In distribution
DZ147A-CAL		In distribution
DZ141A-CAL		In distribution
DZ168C-CAL		In distribution
DZ179A-CAL		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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K131556	2013-06-26
K102638	2010-11-30

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.