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Immunohistology Kits

EUDAMED

Class A (EU MDR)

Ref ABH015Ref AFP600Ref EHP500Ref ACU-5000Ref AMF080Ref ABM008Ref ABG125Ref AMH080Ref ACU999Ref ABL125Ref AKB080Ref ACD015Ref ABL008Ref AFH600Ref ACK999Ref ACB030Ref CPP125Ref EAP125Ref ACU500Ref ACB060Ref ACD999Ref AKA080Ref ACH500Ref EAP500Ref AFA600Ref AKD080Ref ABG015Ref ABM125Ref ACD500Ref ACJ999Ref CPH080Ref ACG500Ref ACU100Ref ACJ500Ref ACK500Ref ACE010Ref ACD030Ref ACB125Ref ABM015Ref AEM080Ref ACV999Ref AFK600Ref AFL600Ref ABH125Ref AEB080

by ScyTek Laboratories Inc.

Identity

Device Name
Immunohistology Kits EUDAMED
Model / Reference
ABH015 EUDAMED
AFP600 EUDAMED
EHP500 EUDAMED
ACU-5000 EUDAMED
AMF080 EUDAMED
ABM008 EUDAMED
ABG125 EUDAMED
AMH080 EUDAMED
ACU999 EUDAMED
ABL125 EUDAMED
AKB080 EUDAMED
ACD015 EUDAMED
ABL008 EUDAMED
AFH600 EUDAMED
ACK999 EUDAMED
ACB030 EUDAMED
CPP125 EUDAMED
EAP125 EUDAMED
ACU500 EUDAMED
ACB060 EUDAMED
ACD999 EUDAMED
AKA080 EUDAMED
ACH500 EUDAMED
EAP500 EUDAMED
AFA600 EUDAMED
AKD080 EUDAMED
ABG015 EUDAMED
ABM125 EUDAMED
ACD500 EUDAMED
ACJ999 EUDAMED
CPH080 EUDAMED
ACG500 EUDAMED
ACU100 EUDAMED
ACJ500 EUDAMED
ACK500 EUDAMED
ACE010 EUDAMED
ACD030 EUDAMED
ACB125 EUDAMED
ABM015 EUDAMED
AEM080 EUDAMED
ACV999 EUDAMED
AFK600 EUDAMED
AFL600 EUDAMED
ABH125 EUDAMED
AEB080 EUDAMED

Identifiers

Primary DI / UDI-DI
00810108713142 EUDAMED
00810108714095 EUDAMED
00810108715351 EUDAMED
00810108719670 EUDAMED
00810108714231 EUDAMED
00810108713340 EUDAMED
00810108713111 EUDAMED
00810108714255 EUDAMED
00810108713807 EUDAMED
00810108713319 EUDAMED
00810108714194 EUDAMED
00810108713630 EUDAMED
00810108713296 EUDAMED
00810108714033 EUDAMED
00810108713753 EUDAMED
00810108713562 EUDAMED
00810108715061 EUDAMED
00810108715306 EUDAMED
00810108713791 EUDAMED
00810108713579 EUDAMED
00850075153138 EUDAMED
00810108714187 EUDAMED
00810108713715 EUDAMED
00810108715313 EUDAMED
00810108713982 EUDAMED
00810108714217 EUDAMED
00810108713104 EUDAMED
00810108713364 EUDAMED
00810108713661 EUDAMED
00810108713739 EUDAMED
00810108715023 EUDAMED
00810108713708 EUDAMED
00810108719724 EUDAMED
00810108713722 EUDAMED
00810108713746 EUDAMED
00810108713678 EUDAMED
00810108713647 EUDAMED
00810108713586 EUDAMED
00810108713357 EUDAMED
00810108713937 EUDAMED
00810108713838 EUDAMED
00810108714057 EUDAMED
00810108714064 EUDAMED
00810108713159 EUDAMED
00810108713906 EUDAMED
Basic UDI-DI
081010871W01030711F5 EUDAMED
Direct Marketing DI
00810108713142 EUDAMED
00810108714095 EUDAMED
00810108715351 EUDAMED
00810108719670 EUDAMED
00810108714231 EUDAMED
00810108713340 EUDAMED
00810108713111 EUDAMED
00810108714255 EUDAMED
00810108713807 EUDAMED
00810108713319 EUDAMED
00810108714194 EUDAMED
00810108713630 EUDAMED
00810108713296 EUDAMED
00810108714033 EUDAMED
00810108713753 EUDAMED
00810108713562 EUDAMED
00810108715061 EUDAMED
00810108715306 EUDAMED
00810108713791 EUDAMED
00810108713579 EUDAMED
00850075153138 EUDAMED
00810108714187 EUDAMED
00810108713715 EUDAMED
00810108715313 EUDAMED
00810108713982 EUDAMED
00810108714217 EUDAMED
00810108713104 EUDAMED
00810108713364 EUDAMED
00810108713661 EUDAMED
00810108713739 EUDAMED
00810108715023 EUDAMED
00810108713708 EUDAMED
00810108719724 EUDAMED
00810108713722 EUDAMED
00810108713746 EUDAMED
00810108713678 EUDAMED
00810108713647 EUDAMED
00810108713586 EUDAMED
00810108713357 EUDAMED
00810108713937 EUDAMED
00810108713838 EUDAMED
00810108714057 EUDAMED
00810108714064 EUDAMED
00810108713159 EUDAMED
00810108713906 EUDAMED
EMDN Code
W01030711 IMMUNOHISTOLOGY KITS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Immunohistology Kits by ScyTek Laboratories Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ScyTek Laboratories Inc.
EUDAMED SRN
US-MF-000023816
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (45)

  • EUDAMED 8c0710e6-f0a9-47b4-b2c4-8da4a9f093d7 61 fields · synced Sep 18, 2026
  • EUDAMED c7985be7-482c-4a1e-aebe-430461fed791 61 fields · synced May 11, 2026
  • EUDAMED 159999b3-6a9d-4131-906e-78fc082e2f51 61 fields · synced May 11, 2026
  • EUDAMED f9695da6-27ca-4bc9-bbfb-1d6dd9d45446 61 fields · synced May 16, 2026
  • EUDAMED 47e16d84-6806-4c05-992a-5e9e39f6aafd 61 fields · synced May 16, 2026
  • EUDAMED 9575ee41-ba65-4da0-b888-4bd8232ab426 61 fields · synced May 16, 2026
  • EUDAMED 54fe7bc0-c3d0-4431-a894-8a4271e284a0 61 fields · synced May 16, 2026
  • EUDAMED aa5e45fb-88a0-44db-aabf-3effc5c3a071 61 fields · synced May 17, 2026
  • EUDAMED e88298a2-f309-4724-97f9-cbce0cae667c 61 fields · synced May 17, 2026
  • EUDAMED 238c645b-5921-4baa-aa27-8c9089c52343 61 fields · synced May 17, 2026
  • EUDAMED 02fccb71-66b3-4433-b2fa-deeb6115c18c 61 fields · synced May 17, 2026
  • EUDAMED 074fe71b-ee20-43cc-aabf-0a68b0e86753 61 fields · synced May 17, 2026
  • EUDAMED bd8d078c-564c-4baf-a194-69704e6e756e 61 fields · synced May 17, 2026
  • EUDAMED 76942d60-0cb1-4617-ab76-7652b0de10d5 61 fields · synced May 17, 2026
  • EUDAMED 23b1ec34-1508-4212-b20a-1685d6aff908 61 fields · synced May 17, 2026
  • EUDAMED 554c22a5-ff62-448d-b7bb-2d6a50a0f080 61 fields · synced May 17, 2026
  • EUDAMED e1842260-9058-438d-8b2b-e4b2305f1d7c 61 fields · synced May 17, 2026
  • EUDAMED 6b96c0d4-abf8-40e5-ad7a-f1491f95a8e5 61 fields · synced May 17, 2026
  • EUDAMED f0168746-8ed8-4548-ad98-cb2a970ed4b4 61 fields · synced May 17, 2026
  • EUDAMED 1ad36d86-41cd-4646-9e3e-708e3a987ec7 61 fields · synced May 17, 2026
  • EUDAMED 93098815-259c-40ca-8b99-deb9c3133a2d 61 fields · synced May 17, 2026
  • EUDAMED cfbdb774-4bd8-4204-b1fb-7d1595abfcdf 61 fields · synced May 17, 2026
  • EUDAMED 7eedf639-ce05-4114-afc4-a10913a34a3d 61 fields · synced May 17, 2026
  • EUDAMED 639ab247-a470-4103-b3f8-bac06c9d9aba 61 fields · synced May 17, 2026
  • EUDAMED 33751169-b591-4bb8-bdd7-6b571adeb082 61 fields · synced May 17, 2026
  • EUDAMED b51d2993-2398-4795-ad1d-4f10fb35c2ec 61 fields · synced May 18, 2026
  • EUDAMED 87105d7c-44d3-497f-a9ed-45870bc3c6ac 61 fields · synced May 18, 2026
  • EUDAMED 73f02020-e065-40f0-836e-c023c8519e40 61 fields · synced May 18, 2026
  • EUDAMED 176ffc2e-8085-493e-a9b8-b2b394eef0c3 61 fields · synced May 18, 2026
  • EUDAMED 5fc9fd80-ee5f-434f-9367-616d7d3e65cd 61 fields · synced May 18, 2026
  • EUDAMED c5c03dc5-a816-4b33-aa18-1b5736ce759d 61 fields · synced May 18, 2026
  • EUDAMED 7b8a3c11-f52b-4139-96a4-c923b8fa145d 61 fields · synced May 18, 2026
  • EUDAMED 70aaed21-1ca7-4580-bf1d-6fa9398195db 61 fields · synced May 18, 2026
  • EUDAMED 15a37ed2-b68e-4377-b754-a0402fbec97f 61 fields · synced May 18, 2026
  • EUDAMED 64eddb8f-fcc6-4a5c-bb62-3c4c1684f2a2 61 fields · synced May 18, 2026
  • EUDAMED b98485de-57f1-48d4-ab69-7b80e4a39b2f 61 fields · synced May 18, 2026
  • EUDAMED 9762c461-96a6-4fdf-aabb-94013aa1a73a 61 fields · synced May 18, 2026
  • EUDAMED c6750060-b416-4782-9adc-0fb0a28da381 61 fields · synced May 18, 2026
  • EUDAMED d4c94464-f577-407c-9176-8a282a1f7840 61 fields · synced May 18, 2026
  • EUDAMED 6ea6ea82-f5ed-4916-9f2c-b82739be7ca8 61 fields · synced May 19, 2026
  • EUDAMED fb76c02d-b49a-4ce7-94bc-cbbddd98000c 61 fields · synced May 19, 2026
  • EUDAMED 54bddb2a-b4b0-4305-a0b1-d4094c939c3a 61 fields · synced May 19, 2026
  • EUDAMED efa4e506-f01e-44ee-bf89-f67811b6dc87 61 fields · synced May 19, 2026
  • EUDAMED 0cc3fd1f-bb85-4501-bdd4-fbbe2b21991e 61 fields · synced May 19, 2026
  • EUDAMED f26e5345-9c55-4fdf-b3cd-87c8fed21ff2 61 fields · synced May 19, 2026