Identity
- Trade Name
- BOND-PRIME FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- The BOND-PRIME ARC Refresh Kit is a consumable kit for the BOND-PRIME staining platform. The kit contains two items that must be periodically replaced to maintain staining quality: a set of BOND-PRIME Covertiles and a BOND-PRIME Mixing Well Plate. FDA UDI
- Model / Reference
- BOND-PRIME ARC REFRESH KIT FDA UDI
- Description
- The BOND-PRIME ARC Refresh Kit is a consumable kit for the BOND-PRIME staining platform. The kit contains two items that must be periodically replaced to maintain staining quality: a set of BOND-PRIME Covertiles and a BOND-PRIME Mixing Well Plate. FDA UDI
Identifiers
- Catalog Number
- 91.1592 FDA UDI
- Primary DI / UDI-DI
- 09349458005436 FDA UDI
- FDA Product Code
- KPA FDA UDI
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3800 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microscope slide stainer IVD
Bond-Prime by Leica Biosystems Melbourne Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microscope slide stainer IVD.
- Hematek® 3000 System — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Rack holder, assy. — Leica Biosystems Nussloch GmbH · Class I
- Tinto Detector Complete System — BIO SB, INC. · Class I
- intelliPATH MAX — BIOCARE MEDICAL, LLC · Class I
- BOND-MAX Processing Module Laboratory - Automated Slide Stainer — LEICA BIOSYSTEMS MELBOURNE PTY LTD · Class A
- HistoPro® — RUSHABH INSTRUMENTS, LLC · Class I
- Dako Omnis — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Xmatrx® Nano — Biogenex Laboratories, Inc. · 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 Melbourne Pty Ltd
Sources (1)
- FDA UDI 46db7df8-1849-4599-b4a2-a9b5140bcf23 34 fields · synced Jun 8, 2026