Who else makes this device?

Name: STROMATOLYSER-3WP
Brand: STROMATOLYSER-3WP

Hematology › ReagentsProducts, Red-Cell Lysing Products

STROMATOLYSER-3WP

STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC counts and tri-modal WBC distribution analysis. STROMATOLYSER-3WP…

Registry build 21.09.26

STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC counts and tri-modal WBC distribution analysis. STROMATOLYSER-3WP is a clear reagent manufactured for use with selected Sysmex Automated Hematology Analyzers.

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (1), Zhejiang (1), Shandong (1).

Chinese manufacturers registered for FDA product code GGK
Manufacturer	City	Province	Registered as	Device types
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Zhejiang Gene Science Co., Ltd.	Shaoxing	Zhejiang	Manufacturer	31
B&E BIO-Technology Co., Ltd.	Yantai	Shandong	Manufacturer	9

Record

Regulatory record for STROMATOLYSER-3WP
Listed by	Sysmex Corporation, Japan
FDA product code	GGK
Device type	Products, Red-Cell Lysing Products
Device class	Class 1
Regulation	21 CFR 864.8540
Establishment	Manufacturer, Exporter
Premarket notification	Exempt
Record published	2022-11-30

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 35 °C
Sizes	Total volume 5 l

Catalogue Numbers

Catalogue numbers for STROMATOLYSER-3WP
Catalogue number	Size	Status
85400121	Total Volume 5 l	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cell-DYN	Abbott Laboratories	14
Drew Scientific	Drew Scientific, Ltd.	7
Beckmancoulter	Immunotech Corp.	4
Coulter Lyse S III diff Lytic Reagent	Beckman Coulter, Inc.	4
Lysercell WDF	Sysmex Corporation	4
Beckman coulter	Immunotech Corp.	4
STROMATOLYSER-4DL	Sysmex Corporation	3
M-30CFL Lyse	Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	3
Sulfolyser	Sysmex Corporation	3
Coulter Lyse S 4 Lytic Reagent	Beckman Coulter, Inc.	2
M-5LEO(II) Lyse	Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	2
Coulter diff Ac•T PAK Reagent Kit	Beckman Coulter, Inc.	2

Showing 12 of 79. All products under Products, Red-Cell Lysing Products

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K790029	1979-02-26

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.