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Secondary Antisera
EUDAMEDClass A (EU MDR)
Ref ABJ125Ref PAM500Ref ABJ500Ref ABC015Ref ABC500Ref PAR125Ref PAM015Ref ABK999Ref ABN008Ref ABK125Ref AGL250Ref PAL015Ref ABC008Ref ABC125Ref ABE125Ref ABJ008Ref ABZ999Ref ABZ015Ref AGL015Ref AGL008Ref ABE015Ref PAM999Ref PAR008Ref ABF500Ref PAM008Ref ABN125Ref PAL500Ref ABF125Ref AGL125Ref ABZ008
Identity
- Device Name
- Secondary Antisera EUDAMED
- Model / Reference
- ABJ125 EUDAMEDPAM500 EUDAMEDABJ500 EUDAMEDABC015 EUDAMEDABC500 EUDAMEDPAR125 EUDAMEDPAM015 EUDAMEDABK999 EUDAMEDABN008 EUDAMEDABK125 EUDAMEDAGL250 EUDAMEDPAL015 EUDAMEDABC008 EUDAMEDABC125 EUDAMEDABE125 EUDAMEDABJ008 EUDAMEDABZ999 EUDAMEDABZ015 EUDAMEDAGL015 EUDAMEDAGL008 EUDAMEDABE015 EUDAMEDPAM999 EUDAMEDPAR008 EUDAMEDABF500 EUDAMEDPAM008 EUDAMEDABN125 EUDAMEDPAL500 EUDAMEDABF125 EUDAMEDAGL125 EUDAMEDABZ008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810108713210 EUDAMED00810108717041 EUDAMED00810108713227 EUDAMED00810108712978 EUDAMED00810108712992 EUDAMED00810108717157 EUDAMED00810108717027 EUDAMED00810108713289 EUDAMED00810108713395 EUDAMED00810108713265 EUDAMED00810108714170 EUDAMED00810108716976 EUDAMED00810108712961 EUDAMED00810108712985 EUDAMED00810108713036 EUDAMED00810108713197 EUDAMED00810108713517 EUDAMED00810108713487 EUDAMED00810108714156 EUDAMED00810108714149 EUDAMED00810108713029 EUDAMED00810108717058 EUDAMED00810108717133 EUDAMED00810108713081 EUDAMED00810108717010 EUDAMED00810108713418 EUDAMED00810108716990 EUDAMED00810108713074 EUDAMED00810108714163 EUDAMED00810108713470 EUDAMED
- Basic UDI-DI
- 081010871W01030710F3 EUDAMED
- Direct Marketing DI
- 00810108713210 EUDAMED00810108717041 EUDAMED00810108713227 EUDAMED00810108712978 EUDAMED00810108712992 EUDAMED00810108717157 EUDAMED00810108717027 EUDAMED00810108713289 EUDAMED00810108713395 EUDAMED00810108713265 EUDAMED00810108714170 EUDAMED00810108716976 EUDAMED00810108712961 EUDAMED00810108712985 EUDAMED00810108713036 EUDAMED00810108713197 EUDAMED00810108713517 EUDAMED00810108713487 EUDAMED00810108714156 EUDAMED00810108714149 EUDAMED00810108713029 EUDAMED00810108717058 EUDAMED00810108717133 EUDAMED00810108713081 EUDAMED00810108717010 EUDAMED00810108713418 EUDAMED00810108716990 EUDAMED00810108713074 EUDAMED00810108714163 EUDAMED00810108713470 EUDAMED
- EMDN Code
- W01030710 SECONDARY ANTISERA FOR IMMUNOHISTOLOGY 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
Secondary Antisera by ScyTek Laboratories Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081010871W01030710F3 | Class A | Active |
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Manufacturer
- Manufacturer
- ScyTek Laboratories Inc.
- EUDAMED SRN
- US-MF-000023816
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (30)
- EUDAMED 46602f9e-9e89-4eb5-a990-83e7cc35b689 61 fields · synced Aug 5, 2026
- EUDAMED 68fd32e0-b30f-4bba-9ff2-8398fde58696 61 fields · synced May 11, 2026
- EUDAMED f8a8bc92-82bf-4077-93d6-4a7c2031adc0 61 fields · synced May 11, 2026
- EUDAMED 3e9955ff-2f97-4397-9004-7f7bbeff2258 61 fields · synced May 16, 2026
- EUDAMED f7c5b76a-e610-493e-ab25-7c5dd583b768 61 fields · synced May 16, 2026
- EUDAMED 658200d6-068b-452f-a2eb-3e9ab49ccd3d 61 fields · synced May 17, 2026
- EUDAMED f652c6be-2c74-46d5-9931-667096163fbf 61 fields · synced May 17, 2026
- EUDAMED 0e85de85-792d-4be1-9ca3-912093564332 61 fields · synced May 17, 2026
- EUDAMED b789664a-c08f-423e-b335-72ecf1c17495 61 fields · synced May 17, 2026
- EUDAMED fea2042f-344b-46bb-9d72-f1cd24fe1a15 61 fields · synced May 17, 2026
- EUDAMED eecf723b-6112-4e5d-a215-6e227584f0e6 61 fields · synced May 17, 2026
- EUDAMED a278aa47-81bb-4d6d-92ec-393219f0ff77 61 fields · synced May 17, 2026
- EUDAMED c9670ab8-e243-4cf8-adb4-9f0104120fc6 61 fields · synced May 17, 2026
- EUDAMED dca98d32-9983-40e7-b7b9-3fe4851b2e7f 61 fields · synced May 17, 2026
- EUDAMED effecfb0-a7e6-4819-8eca-bb6898af26d9 61 fields · synced May 17, 2026
- EUDAMED 67080d4d-d13a-49cf-9e4c-8cd32c605f89 61 fields · synced May 17, 2026
- EUDAMED 9235f5d8-45e9-474f-bf51-165c9cbd9588 61 fields · synced May 18, 2026
- EUDAMED 35b17e67-e652-43df-9290-f939a263245a 61 fields · synced May 18, 2026
- EUDAMED 668a6a41-30cc-47ab-82ec-9292e6638851 61 fields · synced May 18, 2026
- EUDAMED 7c010ba6-8db7-439c-b5e5-ef5bcef8a805 61 fields · synced May 18, 2026
- EUDAMED 45d18d63-9a7a-4466-8ce4-56168bcd8343 61 fields · synced May 18, 2026
- EUDAMED 65dab30f-7bd8-486e-b635-2e38e37ff36c 61 fields · synced May 18, 2026
- EUDAMED 70d54bf7-aa14-4620-83c6-584ec7471924 61 fields · synced May 18, 2026
- EUDAMED b3f4d861-a149-4cfb-9b69-cc1738b0724f 61 fields · synced May 18, 2026
- EUDAMED 6d96eb5b-9629-406d-8967-05ee70da81bd 61 fields · synced May 18, 2026
- EUDAMED 98634caa-47d3-4b80-8363-aec3d38fd5ae 61 fields · synced May 18, 2026
- EUDAMED 90aee8fb-2967-4635-9316-0aee33621be9 61 fields · synced May 18, 2026
- EUDAMED 7cc9d3d4-2cd0-4e77-b6aa-141c7c997bfc 61 fields · synced May 18, 2026
- EUDAMED b17654a3-78ac-4529-ba30-15384c0a402a 61 fields · synced May 19, 2026
- EUDAMED a4d8ed28-384a-414c-8b92-e003163c0236 61 fields · synced May 19, 2026