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Cytokeratin 7 (OV-TL 12/30) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 307M-95Model 307M-9X seriesRef 307M-94Ref 307M-96Ref 307M-98
Identity
- Trade Name
- Cytokeratin 7 (OV-TL 12/30) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Cytokeratin IVD, antibody FDA UDI
- Device Name
- Cytokeratin 7 (OV-TL 12/30) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 307M-94 EUDAMEDFDA UDI307M-96 EUDAMEDFDA UDI307M-95 EUDAMEDFDA UDI307M-98 EUDAMEDFDA UDI307M-9X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683134671 EUDAMEDFDA UDI00841683134695 EUDAMEDFDA UDI00841683134688 EUDAMEDFDA UDI00841683134718 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831307M-9CH EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Cytokeratin IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
New Device
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
No
FDA UDI
Category: Cytokeratin IVD, antibody
Cytokeratin 7 (OV-TL 12/30) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (8)
- FDA UDI 486c4917-e0f6-4941-ad84-9d1ea1e06d6c 33 fields · synced Oct 6, 2026
- FDA UDI 738e5d72-06c3-4e6d-9ea4-dbd505c4570b 33 fields · synced May 30, 2026
- FDA UDI a7f33113-43fc-49ac-89e8-2b5b3201185a 33 fields · synced May 30, 2026
- FDA UDI 0551806a-d128-4cf3-bd75-06b9a6abdb2e 33 fields · synced May 30, 2026
- EUDAMED 0738215c-e0ef-4137-8985-243ff2ed441a 61 fields · synced Jul 9, 2026
- EUDAMED 4309dfb8-259d-4ad3-9ce6-ee80f76bdc7a 61 fields · synced Jul 11, 2026
- EUDAMED fdc03624-86e9-4e71-8de9-7347d073723d 61 fields · synced Jul 22, 2026
- EUDAMED e302eb9d-296d-4700-86be-5888ce7aea76 61 fields · synced Aug 1, 2026