Identity
- Trade Name
- Tissue-Tek Genie® anti-Cytokeratin 19 Mouse Monoclonal Antibody [A53-B/A2.26] EUDAMEDTissue-Tek Genie® FDA UDI
- Generic Name
- Cytokeratin IVD, antibody FDA UDI
- Device Name
- Tissue-Tek Genie® anti-Cytokeratin 19 Mouse Monoclonal Antibody [A53-B/A2.26] EUDAMEDanti-Cytokeratin 19 Mouse Monoclonal Antibody [A53-B/A2.26], 10 RTU capsules FDA UDI
- Model / Reference
- 8303-C010 EUDAMEDFDA UDI
- Description
- anti-Cytokeratin 19 Mouse Monoclonal Antibody [A53-B/A2.26], 10 RTU capsules FDA UDI
Identifiers
- Catalog Number
- 8303-C010 FDA UDI
- Primary DI / UDI-DI
- 00615233001313 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00615233001313 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
- GMDN Term
- Cytokeratin IVD, antibody FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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: Cytokeratin IVD, antibody
Tissue-Tek Genie® by Sakura Finetek USA, Inc — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cytokeratin IVD, antibody.
- ANTI-CYTOKERATIN PAN — Biogenex Laboratories, Inc. · Class I
- Rabbit Monoclonal Anti-Human Cytokeratin 13 Antibody, EP69 — EPITOMICS, INC. · Class I
- Mouse Monoclonal Anti-Human CK-HMW(MX134) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Cytokeratin 17 RMab — BIO SB, INC. · Class I
- Tinto Cytokeratin 7 & CDX2, RMab — BIO SB, INC. · Class I
- Cytokeratin 13 RMab — BIO SB, INC. · Class I
- Novocastra™ — Leica Biosystems Newcastle, Limited · Class I
- Rabbit Monoclonal Anti-Human Cytokeratin 19 Antibody, EP72 — EPITOMICS, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sakura Finetek USA, Inc
Sources (2)
- FDA UDI f05d61b3-90f4-4d2f-bcc9-f3680c146911 35 fields · synced Oct 8, 2026
- EUDAMED 8948bf78-3d69-4bf7-99d2-73fa2c6427e9 61 fields · synced Oct 8, 2026