Identity
- Trade Name
- OncoMate MSI Dx Analysis System FDA UDI
- Generic Name
- Microsatellite instability IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections. FDA UDI
- Model / Reference
- MD2140 FDA UDI
- Description
- Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections. FDA UDI
Identifiers
- Catalog Number
- MD2140 FDA UDI
- Primary DI / UDI-DI
- 00849811031717 FDA UDI
- 510(k) Number
- K200129 FDA UDI
- FDA Product Code
- PZJ FDA UDI
- GMDN Term
- Microsatellite instability IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.1866 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Microsatellite instability IVD, kit, nucleic acid technique (NAT)
OncoMate MSI Dx Analysis System by Promega Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microsatellite instability IVD, kit, nucleic acid technique (NAT).
- Idylla™ MSI Test — Biocartis NV · Class II
- OncoMate MSI Dx Assay Installer — Promega Corporation · Class II
- OncoMate MSI Dx Interpretive Software — Promega Corporation · Class II
Cleared under the same submission
K200129 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Promega Corporation
Sources (1)
- FDA UDI d0254d6d-f24c-4772-9fc5-f0cf60add546 36 fields · synced Jun 9, 2026