Who else makes this device?

Name: Lymphotype HLA-DR/DQ 72
Brand: Lymphotype HLA-DR/DQ 72

Hematology › Automated Hematology DevicesCounter, Differential Cell

Lymphotype HLA-DR/DQ 72

for 6 detections of human HLA-DR/DQ antigens in the complement-dependent microlymphocytotoxicity test

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

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

Chinese manufacturers registered for FDA product code GKZ
Manufacturer	City	Province	Registered as	Device types
VTech Communications Ltd	Dongguan	Guangdong	Contract manufacturer	5
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Onechipdx Biotech (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Specification developer	2

Record

Regulatory record for Lymphotype HLA-DR/DQ 72
Listed by	BIO-RAD Medical Diagnostics Gmbh, Germany
FDA product code	GKZ
Device type	Counter, Differential Cell
Device class	Class 2
Regulation	21 CFR 864.5220
Establishment	Specification developer, Manufacturer
Record published	2015-07-01
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature up to -20 °C
Distribution end date	2017-10-16

Catalogue Numbers

Catalogue numbers for Lymphotype HLA-DR/DQ 72
Catalogue number	Size	Status
823102		Withdrawn

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Showing 12 of 245. All products under Counter, Differential Cell

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.