Identity
- Trade Name
- Tissue-Tek Genie® FDA UDI
- Generic Name
- B-cell specific activator protein (BSAP) IVD, antibody FDA UDI
- Device Name
- anti-PAX5 Rabbit Monoclonal Antibody [EP156], 1 RTU cartridge FDA UDI
- Model / Reference
- 8500-M250 FDA UDI
- Description
- anti-PAX5 Rabbit Monoclonal Antibody [EP156], 1 RTU cartridge FDA UDI
Identifiers
- Catalog Number
- 8500-M250 FDA UDI
- Primary DI / UDI-DI
- 00615233002242 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- B-cell specific activator protein (BSAP) 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: B-cell specific activator protein (BSAP) 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 B-cell specific activator protein (BSAP) IVD, antibody.
- FLEX Mono Mo A-Hu B-Cell-Specific Activator Protein Cl DAK-Pax5 RTU (Link) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- PAX-5 (24) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- PAX-5 (SP34) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- ANTI-PAX-5 — Biogenex Laboratories, Inc. · Class I
- PAX-5 (SP34) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- PAX5 — BIOCARE MEDICAL, LLC · Class I
- FLEX Mono Mo A-Hu B-Cell-Specific Activator Protein Cl DAK-Pax5 RTU — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- PAX-5 (24) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · 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 84926364-03c4-4e76-b17f-0bd521e5252f 35 fields · synced Jun 8, 2026