Identity
- Trade Name
- BOND FDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, reagent FDA UDI
- Device Name
- BOND Intense R Detection is a biotin/streptavidin system for the detection of tissue-bound 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
- DS9263 FDA UDI
- Description
- BOND Intense R Detection is a biotin/streptavidin system for the detection of tissue-bound 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
- DS9263 FDA UDI
- Primary DI / UDI-DI
- 05055331310507 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Immunohistochemistry antibody detection IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Immunohistochemistry antibody detection IVD, reagent
Bond by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunohistochemistry antibody detection IVD, reagent.
- MACH 2 Mouse AP-Polymer — BIOCARE MEDICAL, LLC · Class I
- Pepsin for antigen retrieval (RTU) — VITRO SA · Class I
- Rabbit Amp AP Detection — BIOCARE MEDICAL, LLC · Class I
- MACH 2 Double Stain 1 — BIOCARE MEDICAL, LLC · Class I
- MACH 2 Mouse HRP-Polymer — BIOCARE MEDICAL, LLC · Class I
- MACH 2 Double Stain 1 — BIOCARE MEDICAL, LLC · Class I
- Denaturing Solution Kit — BIOCARE MEDICAL, LLC · Class I
- OX40/CD134 — BIOCARE MEDICAL, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI c7bb35c9-9ca4-465b-a748-0f93dc25d5a4 36 fields · synced May 30, 2026