Who else makes this device?

Name: e-CHECK(XS)
Brand: e-CHECK(XS)

e-CHECK(XS) · Mixture, Control, White-Cell and Red-Cell Indices → Hematology

1manufacturer

1catalogue number

Who Else Makes It

Registered in Jilin.

Chinese manufacturers registered for FDA product code GLQ
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84

Record

Regulatory record for e-CHECK(XS)
Listed by	Sysmex Corporation, Japan
FDA product code	GLQ
Device type	Mixture, Control, White-Cell And Red-Cell Indices
Device class	Class 2
Regulation	21 CFR 864.8625
Establishment	Manufacturer, Exporter
510(k)	K994388
Record published	2016-08-05
Record revised	2018-09-18 (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
Storage	Storage environment temperature 2 to 8 °C
Sizes	Total volume 1.5 ml

Catalogue Numbers

Catalogue numbers for e-CHECK(XS)
Catalogue number	Size	Status
199-5002-0	Total Volume 1.5 ml	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Para 12 Extend	Streck LLC	11
Cell-Chex	Streck LLC	7
STaK-Chex Plus Retics	Streck LLC	6
Cell-DYN	Abbott Laboratories	6
Alinity	Abbott Medical	2

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.

e-CHECK(XS)

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies