Identity
- Trade Name
- Procleix Ultrio Elite Assay FDA UDI
- Generic Name
- HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors. FDA UDI
- Model / Reference
- Positive Calibrator Kit FDA UDI
- Description
- The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859882007696 FDA UDI
- GMDN Term
- HIV1/HIV2/Hepatitis C virus/Hepatitis B 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: HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Procleix Ultrio Elite Assay by Grifols Diagnostic Solutions Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT).
- Procleix Ultrio Elite Assay — Grifols Diagnostic Solutions Inc.
- Procleix Ultrio Elite Assay — Grifols Diagnostic Solutions Inc.
- Procleix Ultrio Elite Assay — Grifols Diagnostic Solutions Inc.
- Procleix Ultrio Elite Assay — Grifols Diagnostic Solutions Inc.
- Procleix Ultrio Elite Assay — Grifols Diagnostic Solutions Inc.
- Procleix Ultrio Elite Assay — Grifols Diagnostic Solutions Inc.
- Procleix Ultrio Elite Assay — Grifols Diagnostic Solutions Inc.
- Procleix Ultrio Elite Assay — Grifols Diagnostic Solutions Inc.
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 |
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Manufacturer
- Manufacturer
- Grifols Diagnostic Solutions Inc.
Sources (1)
- FDA UDI 6cc68c37-e402-43f9-a4aa-59edd9bbd4dc 33 fields · synced Jun 9, 2026