Identity
- Trade Name
- Procleix Zika Virus Assay FDA UDI
- Generic Name
- Zika virus nucleic acid IVD, calibrator FDA UDI
- Device Name
- The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the detection of Zika virus (ZIKV) RNA in plasma and serum specimens from human donors. FDA UDI
- Model / Reference
- 1K Calibrators FDA UDI
- Description
- The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the detection of Zika virus (ZIKV) RNA in plasma and serum specimens from human donors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859882007481 FDA UDI
- GMDN Term
- Zika virus nucleic acid IVD, calibrator FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Category: Zika virus nucleic acid IVD, calibrator
Procleix Zika Virus Assay by Grifols Diagnostic Solutions Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Zika virus nucleic acid IVD, calibrator.
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Grifols Diagnostic Solutions Inc.
Sources (1)
- FDA UDI 06d8f6e5-a11c-4fab-b911-0b67cd54fa99 33 fields · synced Jun 9, 2026