Identity
- Trade Name
- BOND™ FDA UDI
- Generic Name
- Cancer antigen 19-9 (CA19-9) GI IVD, antibody FDA UDI
- Device Name
- CA19-9 (Sialyl Lewis a) (C241:5:1:4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Sialyl Lewis a 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
- PA0424-U FDA UDI
- Description
- CA19-9 (Sialyl Lewis a) (C241:5:1:4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Sialyl Lewis a 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
- PA0424-U FDA UDI
- Primary DI / UDI-DI
- 05055331335067 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Cancer antigen 19-9 (CA19-9) GI 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: Cancer antigen 19-9 (CA19-9) GI IVD, antibody
Bond™ by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cancer antigen 19-9 (CA19-9) GI IVD, antibody.
- CA 19-9 — BIOCARE MEDICAL, LLC · Class I
- CA 19-9 — BIOCARE MEDICAL, LLC · Class I
- CA 19-9 — BIOCARE MEDICAL, LLC · Class I
- ANTI-CA19-9 — Biogenex Laboratories, Inc. · Class I
- CA19-9 (121SLE) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- CA19-9 (121SLE) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Anti-CA19-9 — Biogenex Laboratories, Inc. · Class I
- CA19-9 (121SLE) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · 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 2f57f1b0-ec74-4d4e-97ce-2aec245022f8 36 fields · synced May 30, 2026