Identity
- Trade Name
- c-Myc (RBT-CMYC) FDA UDI
- Generic Name
- c-MYC proto-oncogene protein IVD, antibody FDA UDI
- Device Name
- c-Myc is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
- Model / Reference
- BSB-3813-01 FDA UDI
- Description
- c-Myc is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
Identifiers
- Catalog Number
- BSB-3813-01 FDA UDI
- Primary DI / UDI-DI
- B502BSB3813010 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- c-MYC proto-oncogene 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
Dimensions & Sizes
- Size
- Total Volume — 0.1 Milliliter FDA UDI
Category: c-MYC proto-oncogene protein IVD, antibody
c-Myc (RBT-CMYC) by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as c-MYC proto-oncogene protein IVD, antibody.
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- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Anti-C-myc-Protein — Biogenex Laboratories, Inc. · Class I
- c-Myc — BIOCARE MEDICAL, LLC · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, 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
- Bio Sb, Inc.
Sources (1)
- FDA UDI e0971257-f302-4cc4-9777-45f00f6f9a52 37 fields · synced Jun 8, 2026