Identity
- Trade Name
- BOND FDA UDI
- Generic Name
- Caldesmon protein IVD, antibody FDA UDI
- Device Name
- This reagent is for in vitro diagnostic use. H-Caldesmon (BSB-19) is intended to be used for the qualitative identification by light microscopy of human H-Caldesmon protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. FDA UDI
- Model / Reference
- PA0713-U FDA UDI
- Description
- This reagent is for in vitro diagnostic use. H-Caldesmon (BSB-19) is intended to be used for the qualitative identification by light microscopy of human H-Caldesmon protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. FDA UDI
Identifiers
- Catalog Number
- PA0713-U FDA UDI
- Primary DI / UDI-DI
- 05055331336330 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Caldesmon protein 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: Caldesmon protein 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 Caldesmon protein IVD, antibody.
- Caldesmon (E89) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- h-Caldesmon (hHCD) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- FLEX Mono Mo A-Hu Caldesmon, Cl h-CD, RTU (Dako Omnis) — Agilent Technologies Inc. · Class I
- Rabbit Monoclonal Anti-Human Caldesmon Antibody, EP19 — EPITOMICS, INC. · Class I
- Anti-Caldesmon, HMW — Biogenex Laboratories, Inc. · Class I
- Rabbit Monoclonal Anti-Human Caldesmon Antibody, EP19 — EPITOMICS, INC. · Class I
- h-Caldesmon (hHCD) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- CALDESMON HMW, SMOOTH MUSCLE — 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 |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 8f0247ef-4bb2-448b-bff4-be89c66375d5 36 fields · synced May 31, 2026