Identity
- Trade Name
- h-Caldesmon (hHCD) Mouse Monoclonal Antibody FDA UDI
- Generic Name
- Caldesmon protein IVD, antibody FDA UDI
- Model / Reference
- 451M-15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683118633 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
No
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
h-Caldesmon (hHCD) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Caldesmon protein IVD, antibody.
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- Rabbit Monoclonal Anti-Human Caldesmon Antibody, EP19 — EPITOMICS, INC. · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class I
- CALDESMON HMW, SMOOTH MUSCLE — Biogenex Laboratories, Inc. · Class I
- ANTI-CALDESMON — Biogenex Laboratories, Inc. · Class I
- ANTI-CALDESMON — 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
- Cell Marque Corporation
Sources (1)
- FDA UDI 934df8b6-6b25-4d2f-b80f-b1b8c517231e 33 fields · synced Jun 1, 2026