Identity
- Trade Name
- Tinto MDM2 (RBT-MDM2) FDA UDI
- Generic Name
- Mouse double minute 2 (MDM2) protein IVD, antibody FDA UDI
- Device Name
- Tinto MDM2 is a mouse 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-3827-7 FDA UDI
- Description
- Tinto MDM2 is a mouse 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-3827-7 FDA UDI
- Primary DI / UDI-DI
- B502BSB382770 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Mouse double minute 2 (MDM2) 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 — 7 Milliliter FDA UDI
Category: Mouse double minute 2 (MDM2) protein IVD, antibody
Tinto MDM2 (RBT-MDM2) by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mouse double minute 2 (MDM2) protein IVD, antibody.
- Mouse Monoclonal Anti-Human MDM2(MX133) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Anti-MDM2 — Biogenex Laboratories, Inc. · Class I
- Mouse Monoclonal Anti-Human MDM2(MX133) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Mouse Monoclonal Anti-Human MDM2(MX133) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Mouse Monoclonal Anti-Human MDM2(MX133) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Tinto MDM2 (RBT-MDM2) — BIO SB, INC. · Class I
- Tinto MDM2 (RBT-MDM2) — BIO SB, 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 6a09bd1e-6dee-4e29-a02a-c4eb4da98e18 37 fields · synced Jun 6, 2026