Identity
- Trade Name
- Tinto Cyclin D1, RMab FDA UDI
- Generic Name
- Cyclin D1 IVD, antibody FDA UDI
- Device Name
- Tinto Cyclin D1 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
- Predilute, 7 ml FDA UDI
- Description
- Tinto Cyclin D1 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 2469 FDA UDI
- Primary DI / UDI-DI
- B502BSB24690 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Cyclin D1 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Cyclin D1 IVD, antibody
Tinto Cyclin D1, RMab: A highly specific and sensitive immunohistochemistry reagent for detecting cyclin D1 in clinical specimens. This device is designed to provide accurate and reliable results for diagnosing various hematological disorders, making it an essential tool in the laboratory setting.
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Also classified as Cyclin D1 IVD, antibody.
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- Cyclin D1 — BIOCARE MEDICAL, LLC · Class I
- IHC — Slmp, LLC · 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 b7c30c77-a4bf-448d-b0d5-c70b24d9e6b2 34 fields · synced Jul 31, 2026