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INSM1 (MRQ-70) Rabbit Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 475R-94Model 475R-9X seriesRef 475R-96Ref 475R-95Ref 475R-97
Identity
- Trade Name
- INSM1 (MRQ-70) Rabbit Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Insulinoma-associated protein 1 (INSM1) IVD, antibody FDA UDI
- Device Name
- INSM1 (MRQ-70) Rabbit Monoclonal Antibody EUDAMED
- Model / Reference
- 475R-96 EUDAMEDFDA UDI475R-95 EUDAMEDFDA UDI475R-94 EUDAMEDFDA UDI475R-97 EUDAMEDFDA UDI475R-9X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04061842188338 EUDAMED04061842188369 EUDAMED04061842188352 EUDAMED04061842188383 EUDAMED00841683107668 FDA UDI00841683107521 FDA UDI00841683104377 FDA UDI00841683107699 FDA UDI
- Basic UDI-DI
- 008416831475R-9FN EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Insulinoma-associated protein 1 (INSM1) 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
- Not 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
INSM1 (MRQ-70) Rabbit Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 f06ad47c-011e-4fa9-8c90-efa63610933d 33 fields · synced Sep 18, 2026
- FDA UDI 2e2e3788-af21-4e20-953c-23736e9bbeaf 34 fields · synced May 30, 2026
- FDA UDI 3945c4c5-5f93-4e67-a9ac-b8de534b3437 34 fields · synced May 30, 2026
- FDA UDI cd9eecb7-0848-4ad2-b3ce-527bfefa945a 34 fields · synced May 30, 2026
- EUDAMED 1619be7e-7929-4006-94ef-9a23c1458c7a 61 fields · synced Jul 8, 2026
- EUDAMED 67cf634f-a22d-4f17-94f3-ab5265decfc8 61 fields · synced Jul 10, 2026
- EUDAMED 0056c1b1-fde5-4e83-8f8f-78e6004ce277 61 fields · synced Jul 30, 2026
- EUDAMED 2a678209-8b0e-4ada-a703-93e2ecf28923 61 fields · synced Sep 18, 2026