HMB-45 (HMB-45) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- HMB-45 (HMB-45) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Glycoprotein 100 (gp100) IVD, antibody FDA UDI
- Device Name
- HMB-45 (HMB-45) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 282M-94 EUDAMEDFDA UDI282M-96 EUDAMEDFDA UDI282M-98 EUDAMEDFDA UDI282M-9X series EUDAMED282M-95 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683132943 EUDAMEDFDA UDI00841683132967 EUDAMEDFDA UDI00841683132981 EUDAMEDFDA UDI00841683132950 FDA UDI
- Basic UDI-DI
- 008416831282M-9DR EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Glycoprotein 100 (gp100) IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Glycoprotein 100 (gp100) IVD, antibody
HMB-45 (HMB-45) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Glycoprotein 100 (gp100) IVD, antibody.
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- HMB-45 + Mart-1 (Melan A) (A103) + Tyrosinase (T311) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
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- HMB-45 + MART-1 (Melan A) (A103) + Tyrosinase (T311) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (7)
- FDA UDI 1a7d28ef-ed85-4235-b8cc-7e5cd13cf056 33 fields · synced Aug 1, 2026
- FDA UDI 0210e63f-7e6b-4b74-a243-f71c2374a896 33 fields · synced May 30, 2026
- FDA UDI 3b46123e-0a21-4d76-a037-9f29a4003a67 33 fields · synced May 30, 2026
- FDA UDI 1db1bf3d-45c1-42b9-9df2-ea4fa314c525 33 fields · synced May 30, 2026
- EUDAMED 105e85c2-4452-430e-ba5c-f920c86c038c 61 fields · synced Jul 24, 2026
- EUDAMED 8f0ed1ab-22f1-40df-8e00-e2c787f5b737 61 fields · synced Jul 28, 2026
- EUDAMED d410f689-a6eb-4036-87dc-15ba4c7ffe86 61 fields · synced Jul 29, 2026