Chromoplex 1 Dual Detection - 50 Test
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- Chromoplex 1 Dual Detection - 50 Test EUDAMEDBOND FDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, reagent FDA UDI
- Device Name
- BOND ChromoPlex 1 Dual Detection EUDAMEDChromoPlex 1 Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker and polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI
- Model / Reference
- DS9477 EUDAMEDDS9665 EUDAMEDFDA UDI
- Description
- ChromoPlex 1 Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker and polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI
Identifiers
- Catalog Number
- DS9665 FDA UDI
- Primary DI / UDI-DI
- 05055331322234 EUDAMEDFDA UDI
- Basic UDI-DI
- 50553313CHRPLE00005S6 EUDAMED
- Direct Marketing DI
- 05055331322234 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
- GMDN Term
- Immunohistochemistry antibody detection IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Chromoplex 1 Dual Detection - 50 Test by Leica Biosystems Newcastle Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry.
- Thermo Scientific — Richard-Allan Scientific LLC · Class I
- Thermo Scientific — Richard-Allan Scientific LLC · Class I
- Thermo Scientific — Richard-Allan Scientific LLC · Class I
- Thermo Scientific — Richard-Allan Scientific LLC · Class I
- p16/ Ki-67 dual stain cytology kit — Yaneng BIOscience (Shenzhen) Co., Ltd. · Class A
- Thermo Scientific — Richard-Allan Scientific LLC · Class I
- ONCORE Pro ISH HRP Detection — BIOCARE MEDICAL, LLC · Class I
- Thermo Scientific — Richard-Allan Scientific LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 50553313CHRPLE00005S6 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leica Biosystems Newcastle Ltd
- EUDAMED SRN
- GB-MF-000020595
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED aed7e4b6-b30b-49a7-98df-a5308c4040cb 61 fields · synced Jun 17, 2026
- FDA UDI 2a504132-90ee-4bdb-b1b8-1957777357fe 36 fields · synced May 30, 2026