Immunohistology Kits
- Risk class
- Class A
- CND nomenclatures code
- W01030711
- Trade name
- BCIP/NBT Solution
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 00810108719861
- Basic UDI
- 081010871W01030711F5
- Version date
- November 15, 2024
- Manufacturer last update
- May 13, 2022
- Active status
- No
- Manufacturer name
- ScyTek Laboratories Inc.
- Country
- United States
- Country type
- NON_EU
- Address
- 205s 600w Logan
- scytek@scytek.com
- SRN
- NL-AR-000000116
- Country
- Netherlands
- Address
- 60 Westervoortsedijk Arnhem
- lst.aus.euauthrep@ul.com
- Telephone
- +31 70 345 8570
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
- Placed on the market
- Netherlands
- Human tissues
- No
- Animal tissues
- Yes
IMMUNOHISTOLOGY KITS
Access comprehensive regulatory information for Immunohistology Kits in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 00810108719861 and manufactured by ScyTek Laboratories Inc. in United States.
This page provides complete registration details including trade name (BCIP/NBT Solution), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.