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DxH 500 Series Lyse

EUDAMEDFDA 510(k)FDA UDI

Class A (EU MDR)

Ref B36846Model DxH 500 Series LyseRef 628028Ref A59925510(k) K081822Model 628027Ref D20332Model B01276

by Beckman Coulter Ireland Inc.

Identity

Trade Name
DxH 500 Series Lyse EUDAMEDFDA UDI
COULTER Retic-X Cell Control EUDAMED
COULTER 6C Cell Control EUDAMED
DxH EUDAMEDFDA UDI
COULTER EUDAMED
COULTER 6C FDA UDI
COULTER Retic-X FDA UDI
Generic Name
Full blood count IVD, control FDA UDI
Reticulocyte count IVD, control FDA UDI
General specimen microscopy slide IVD, single-use FDA UDI
Full blood count IVD, reagent FDA UDI
Device Name
DxH 500 Series Lyse EUDAMEDFDA UDI
COULTER Retic-X Cell Control EUDAMEDFDA UDI
COULTER 6C Cell Control EUDAMEDFDA UDI
Beckman Coulter DxH Slides EUDAMED
Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends, used with the DxH Slidemaker Stainers, fully automated slide preparation and staining device that smears a blood film on a slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to the blood smear on the slide. Beckman Coulter DxH Slides are intended to be used to prepare whole blood samples for histological stains and preservation of blood for microscopic evaluation. FDA UDI
Model / Reference
DxH 500 Series Lyse EUDAMED
B36846 EUDAMEDFDA UDI
628028 EUDAMEDFDA UDI
A59925 EUDAMEDFDA UDI
628027 EUDAMEDFDA UDI
D20332 EUDAMEDFDA UDI
B01276 EUDAMED
Description
COULTER 6C Cell Control FDA UDI
COULTER Retic-X Cell Control FDA UDI
Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends, used with the DxH Slidemaker Stainers, fully automated slide preparation and staining device that smears a blood film on a slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to the blood smear on the slide. Beckman Coulter DxH Slides are intended to be used to prepare whole blood samples for histological stains and preservation of blood for microscopic evaluation. FDA UDI
DxH 500 Series Lyse FDA UDI

Identifiers

Catalog Number
628027 FDA UDI
628028 FDA UDI
D20332 FDA UDI
A59925 FDA UDI
B36846 FDA UDI
Primary DI / UDI-DI
15099590671860 EUDAMEDFDA UDI
D-628028Q9 EUDAMED
D-A59925WS EUDAMED
15099590233778 EUDAMEDFDA UDI
15099590233785 EUDAMEDFDA UDI
15099590798215 EUDAMEDFDA UDI
15099590205553 EUDAMEDFDA UDI
D-628027Q7 EUDAMED
Basic UDI-DI
150995902HEMLYSER6 EUDAMED
B-628028Q9 EUDAMED
B-A59925WS EUDAMED
150995901HEMCONTROL9R EUDAMED
B-628027Q7 EUDAMED
150995901HEMACCESSORYP8 EUDAMED
Unit of Use DI
05099590798218 EUDAMED
510(k) Number
K081822 FDA 510(k)
FDA Product Code
JPK FDA 510(k)FDA UDI
LXG FDA UDI
GGK FDA UDI
EMDN Code
W0202010185 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES EUDAMED
W0103010506 RETICULOCYTE CONTROLS EUDAMED
W0103010599 HAEMATOLOGY CONTROLS - OTHER EUDAMED
W0103010503 MULTILEVEL BLOOD CONTROLS EUDAMED
W0503900201 MICROSCOPE SLIDES EUDAMED
GMDN Term
Full blood count IVD, control FDA UDI
Reticulocyte count IVD, control FDA UDI
General specimen microscopy slide IVD, single-use FDA UDI
Full blood count IVD, reagent FDA UDI

Classification

Device Class
Class A EUDAMED
Class IVD General EUDAMED
Class C EUDAMED
Class II FDA 510(k)FDA UDI
Class I FDA UDI
Legislation / Framework
21 CFR Part 864.8625 FDA 510(k)
Regulation Number
864.8625 FDA 510(k)FDA UDI
862.2050 FDA UDI
864.8540 FDA UDI
Market of Registration
Ireland EUDAMED
Northern Ireland EUDAMED
Austria EUDAMED
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDIFDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMEDEUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMEDEUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

Yes

EUDAMEDEUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDI

DxH 500 Series Lyse by Beckman Coulter Ireland Inc. — Class A — FDA_510K, IVDD, IVDR — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/IVDD

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Beckman Coulter Ireland Inc.
EUDAMED SRN
IE-MF-000000887

Sources (14)

  • EUDAMED d59ecd08-81a1-4f7f-83e5-e89c390f358c 61 fields · synced Oct 6, 2026
  • EUDAMED 2abf659e-eb3a-445c-b7d5-0aae771df989 61 fields · synced May 18, 2026
  • EUDAMED 5659f7e4-3cd2-4179-af04-ce3b309bf819 61 fields · synced May 18, 2026
  • FDA 510(k) K081822 24 fields · synced May 18, 2026
  • FDA UDI 121ef98f-7366-4e0c-b85a-ba8c1dbf46e3 35 fields · synced May 26, 2026
  • FDA UDI 73e70ca2-64ca-4576-ab66-2e1cecacfd22 35 fields · synced May 30, 2026
  • FDA UDI 3ac0bf13-c43e-4be4-824b-4f2c9d681b5e 35 fields · synced May 30, 2026
  • FDA UDI e927ee3a-f862-4682-869f-8f68d3fd3368 35 fields · synced May 30, 2026
  • FDA UDI 59b0ed5a-ba8d-4a66-bebf-1fa1b61754cc 35 fields · synced May 30, 2026
  • EUDAMED e8e4e905-0944-44d2-b6e7-dcf03a6c7ac8 61 fields · synced Jul 10, 2026
  • EUDAMED ec7d49c8-464c-4396-bdff-5b7907e2ab95 61 fields · synced Jul 11, 2026
  • EUDAMED cbd677bb-19a1-4929-9c1c-29a1554f3360 61 fields · synced Jul 12, 2026
  • EUDAMED 0d874ae4-9c5a-4ac2-9117-954b05cc2892 61 fields · synced Jul 14, 2026
  • EUDAMED 0938e169-59b8-45a5-9355-65861c093bfe 61 fields · synced Jul 28, 2026