← Back to catalogue

Procleix Zika Virus Assay

FDA UDI

by Grifols Diagnostic Solutions Inc.

Identity

Trade Name
Procleix Zika Virus Assay FDA UDI
Generic Name
Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) 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 Kit Box 2 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
00859882007467 FDA UDI
GMDN Term
Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

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

Yes

FDA UDI

Category: Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT)

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, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Grifols Diagnostic Solutions Inc.

Sources (1)

  • FDA UDI c64e2792-bec6-415c-ab86-623ec21034a0 33 fields · synced Jun 9, 2026