Identity
- Trade Name
- Tissue-Tek Genie® FDA UDI
- Generic Name
- p40 protein IVD, antibody FDA UDI
- Device Name
- anti-p40 / Myosin Smooth Muscle Antibody Cocktail [BC28/SMMS-1], 1 RTU cartridge FDA UDI
- Model / Reference
- 8342-M250 FDA UDI
- Description
- anti-p40 / Myosin Smooth Muscle Antibody Cocktail [BC28/SMMS-1], 1 RTU cartridge FDA UDI
Identifiers
- Catalog Number
- 8342-M250 FDA UDI
- Primary DI / UDI-DI
- 00615233010179 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- p40 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
Yes
FDA UDI
Category: p40 protein IVD, antibodySmooth muscle myosin IVD, antibody
Tissue-Tek Genie® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Smooth muscle myosin IVD, antibody.
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- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- Myosin, Smooth Muscle (EP166) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- IHC — Slmp, LLC · Class I
- Mouse Monoclonal Anti-Human Myosin Smooth Muscle(MX109) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- ANTI-MYOSIN HEAVY CHAIN — Biogenex Laboratories, Inc. · 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
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI 98fe8698-5737-485c-97d6-4bbef7fee4bb 35 fields · synced Jun 8, 2026