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Oct-4 (MRQ-10) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 309M-14Model 309M-1X seriesRef 309M-18Ref 309M-15Ref 309M-16Ref 760-4392
Identity
- Trade Name
- Oct-4 (MRQ-10) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Oct-4 IVD, antibody FDA UDI
- Device Name
- Oct-4 (MRQ-10) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 760-4392 EUDAMEDFDA UDI309M-18 EUDAMEDFDA UDI309M-16 EUDAMEDFDA UDI309M-15 EUDAMEDFDA UDI309M-14 EUDAMEDFDA UDI309M-1X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683100874 EUDAMEDFDA UDI00841683134794 EUDAMEDFDA UDI00841683121053 EUDAMEDFDA UDI00841683121046 EUDAMEDFDA UDI00841683121039 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831309M-1CF EUDAMED008416831760-43922L EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Oct-4 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
Yes
FDA UDIFDA UDI
Category: Oct-4 IVD, antibody
Oct-4 (MRQ-10) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Oct-4 IVD, antibody.
- Rabbit Monoclonal Anti-Human OCT-4 Antibody, EP143 — EPITOMICS, INC. · Class I
- ANTI-OCT 4 — Biogenex Laboratories, Inc. · Class I
- Rabbit Monoclonal Anti-Human OCT-4 Antibody, EP143 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human OCT-4 Antibody, EP143 — EPITOMICS, INC. · Class I
- OCT 4 [EP143 — Biogenex Laboratories, Inc. · Class I
- Rabbit Monoclonal Anti-Human OCT-4 Antibody, EP143 — EPITOMICS, INC. · Class I
- ANTI- OCT-4 — Biogenex Laboratories, Inc. · Class I
- Oct-4 (MRQ-10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · 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 (10)
- FDA UDI 2ac022ea-94c2-4a8a-a0bf-dd405b89c12c 33 fields · synced Jul 31, 2026
- FDA UDI 4602bed9-80f6-43e8-9b44-bc432e88efc7 33 fields · synced May 30, 2026
- FDA UDI e7c2fff1-1c7e-4cff-b52f-5cb7c0110abd 33 fields · synced May 30, 2026
- FDA UDI 55ef1901-d010-42ed-b2bb-dfafb8bdfcc0 33 fields · synced May 30, 2026
- FDA UDI 8071015f-672d-4fc5-91ab-b372120a2824 33 fields · synced May 30, 2026
- EUDAMED 6bdd561d-6ec5-49f8-87d3-9993218ac16b 61 fields · synced Jul 9, 2026
- EUDAMED 87fe1c0e-2cff-45f7-b4de-7b9a2bb9b46b 61 fields · synced Jul 15, 2026
- EUDAMED c8732485-7315-43bb-9ad0-286cd6ac605a 61 fields · synced Jul 15, 2026
- EUDAMED 04dd2978-deab-4c2a-90a7-34b40ec1a5a1 61 fields · synced Jul 22, 2026
- EUDAMED da6105e0-d7de-464a-be70-0c5957831c26 61 fields · synced Jul 31, 2026