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MMR Negative Control Reagent, Rabbit (Dako Omnis)
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- MMR Negative Control Reagent, Rabbit (Dako Omnis) FDA UDI
- Generic Name
- Negative control immunoglobulin IVD FDA UDI
- Device Name
- MMR Negative Control Reagent, Rabbit (Dako Omnis) FDA UDI
- Model / Reference
- GE102 FDA UDI
- Description
- MMR Negative Control Reagent, Rabbit (Dako Omnis) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700575005268 FDA UDI
- PMA Number
- P250004 FDA UDI
- FDA Product Code
- QNH FDA UDI
- GMDN Term
- Negative control immunoglobulin IVD FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 12 Milliliter FDA UDI
Category: Negative control immunoglobulin IVD
MMR Negative Control Reagent, Rabbit (Dako Omnis) by Agilent Technologies Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Negative control immunoglobulin IVD.
- Mouse IgM FITC Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- ACCURUN® — LGC Clinical Diagnostics, Inc.
- Rabbit Monoclonal Negative Control Ig — Ventana Medical Systems · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- CONFIRM Negative Control Rabbit Ig Antibody — Ventana Medical Systems · Class I
- Simultest — BECTON DICKINSON AND COMPANY · Class II
- Genemed® — Sakura Finetek USA, Inc · Class I
- ACCURUN® — LGC Clinical Diagnostics, Inc.
Cleared under the same submission
P250004 also covers:
- MLH1 IHC pharmDx (Dako Omnis) — Agilent Technologies Inc.
- MMR Negative Control Reagent, Mouse (Dako Omnis) — Agilent Technologies Inc.
- MSH2 IHC pharmDx (Dako Omnis) — Agilent Technologies Inc.
- MSH6 IHC pharmDx (Dako Omnis) — Agilent Technologies Inc.
- PMS2 IHC pharmDx (Dako Omnis) — Agilent Technologies Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Agilent Technologies Inc.
Sources (1)
- FDA UDI 77dd211f-8ffd-4440-9c8a-74efdc64d070 37 fields · synced May 30, 2026