Identity
- Trade Name
- RealTime FDA UDI
- Generic Name
- Zika virus nucleic acid IVD, control FDA UDI
- Device Name
- Abbott RealTime ZIKA Control Kit FDA UDI
- Model / Reference
- 09N27-080 FDA UDI
- Description
- Abbott RealTime ZIKA Control Kit FDA UDI
Identifiers
- Catalog Number
- 09N27-080 FDA UDI
- Primary DI / UDI-DI
- 00884999046757 FDA UDI
- FDA Product Code
- POA FDA UDI
- GMDN Term
- Zika virus nucleic acid IVD, control FDA UDI
Classification
- Device Class
- N 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
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
Category: Zika virus nucleic acid IVD, control
RealTime by Abbott Molecular — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Zika virus nucleic acid 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 N | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA UDI 27588b8c-5995-43f8-9141-65854722db5f 35 fields · synced Jun 6, 2026