DOG1 (SP31) Rabbit Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- DOG1 (SP31) Rabbit Monoclonal Primary Antibody EUDAMEDDOG1 (SP31) Rabbit Monoclonal Antibody FDA UDI
- Generic Name
- Anoctamin-1 (ANO1) IVD, antibody FDA UDI
- Device Name
- DOG1 (SP31) Rabbit Monoclonal Primary Antibody EUDAMED
- Model / Reference
- 760-4590 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683101192 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831760-45902S EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Anoctamin-1 (ANO1) 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Anoctamin-1 (ANO1) IVD, antibody
DOG1 (SP31) Rabbit 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 Anoctamin-1 (ANO1) IVD, antibody.
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- ANTI-DOG1 — Biogenex Laboratories, Inc. · Class I
- Rabbit Monoclonal Anti-Human DOG1 Antibody, EP332 — EPITOMICS, INC. · Class I
- DOG1 — BIOCARE MEDICAL, LLC · Class I
- ANTI-DOG1 — Biogenex Laboratories, Inc. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Mouse Monoclonal Anti-Human DOG1(MX067) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (2)
- FDA UDI 9f3f88c8-9102-45e7-b916-47cd97cf98b7 33 fields · synced Jul 24, 2026
- EUDAMED 495f928c-917b-4574-b307-f5ce2a593e22 61 fields · synced Jul 24, 2026