Identity
- Trade Name
- Tissue-Tek Genie® DUO FDA UDI
- Generic Name
- p40 protein IVD, antibody FDA UDI
- Device Name
- anti-p40 [BC28] / Napsin A [EP205] Antibody Cocktail, 1 RTU cartridge FDA UDI
- Model / Reference
- 8487-M100 FDA UDI
- Description
- anti-p40 [BC28] / Napsin A [EP205] Antibody Cocktail, 1 RTU cartridge FDA UDI
Identifiers
- Catalog Number
- 8487-M100 FDA UDI
- Primary DI / UDI-DI
- 00615233010124 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: Napsin A IVD, antibodyp40 protein IVD, antibody
Tissue-Tek Genie® DUO by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as p40 protein IVD, antibody.
- p40 (M) — BIOCARE MEDICAL, LLC · Class I
- p40 (M) — BIOCARE MEDICAL, LLC · Class I
- FLEX Mono Rb A-Hu p40, Clone DAK-p40, RTU (Dako Omnis) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class I
- p40 [BC28] BSA Free (1.0mg/ml) — BIOCARE MEDICAL, LLC · Class I
- p40 (P) — BIOCARE MEDICAL, LLC · Class I
- p40 (M) — BIOCARE MEDICAL, LLC · Class I
- anti-p40 (SP225) Rabbit Monoclonal Primary Antibody — Ventana Medical Systems · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI 726a8221-deef-4e9d-b2c7-1def3315c1f0 35 fields · synced Jun 8, 2026