Identity
- Trade Name
- RealTime FDA UDI
- Generic Name
- Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, control FDA UDI
- Device Name
- Abbott RealTime IDH2 Control Kit FDA UDI
- Model / Reference
- 08N82-080 FDA UDI
- Description
- Abbott RealTime IDH2 Control Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884999047051 FDA UDI
- FDA Product Code
- OWD FDA UDI
- GMDN Term
- Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, control FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, control
RealTime by Abbott Molecular — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, control.
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 |
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Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA UDI 3bc9d5d7-11d8-44c2-81af-ccb06363151b 35 fields · synced May 30, 2026