Who else makes this device?

Clinical Chemistry › Test SystemsCalibrator, Secondary

Calibrator Kit – Testosterone

Catalogue number Testo Cal, listed by Qualigen, Inc., United States, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

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 Calibrator Kit – Testosterone
Listed by	Qualigen, Inc., United States
FDA product code	JIT
Device type	Calibrator, Secondary
Device class	Class 2
Regulation	21 CFR 862.1150
Establishment	Complaint-file establishment, Manufacturer
510(k)	K022533
Record published	2016-09-16
Record revised	2023-05-03 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Calibrator Kit – Testosterone
Catalogue number	Size	Status
Testo 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
K022533	2002-09-30
K003096	2000-11-30

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.