Identity
- Trade Name
- BOND™ FDA UDI
- Generic Name
- Ki67 antigen IVD, antibody FDA UDI
- Device Name
- Ki67 (K2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of the human Ki67 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems). FDA UDI
- Model / Reference
- PA0230-U FDA UDI
- Description
- Ki67 (K2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of the human Ki67 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems). FDA UDI
Identifiers
- Catalog Number
- PA0230-U FDA UDI
- Primary DI / UDI-DI
- 05055331334671 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Ki67 antigen IVD, antibody 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: Ki67 antigen IVD, antibody
Bond™ by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ki67 antigen IVD, antibody.
- Genemed® — Sakura Finetek USA, Inc · Class I
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- TintoFast Ki-67 RMab — BIO SB, INC. · Class I
- Mono Mo A-Hu Ki-67 Antigen/FITC Cl Ki-67 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- ANTI-KI 67 — Biogenex Laboratories, Inc. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Ki-67 [MIB-1] — BIOCARE MEDICAL, LLC · Class I
- Ki-67 — 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 |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 6ea25372-2dd6-498e-aaef-ed940da24fba 36 fields · synced May 31, 2026