Identity
- Trade Name
- Procleix Ultrio Plus Assay FDA UDI
- Generic Name
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- Controls Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859882007184 FDA UDI
- GMDN Term
- HIV1/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
No
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/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Procleix Ultrio Plus Assay by Grifols Diagnostic Solutions Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT).
- cobas® TaqScreen MPX Test — Roche Molecular Systems, Inc.
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- cobas® TaqScreen MPX Test, v2.0 — Roche Molecular Systems, Inc.
- cobas® MPX (480 tests) — Roche Diagnostics Corp.
- cobas® MPX (96 tests) — Roche Diagnostics Corp.
- COBAS® AmpliScreen HIV-1 Test, v1.5 — Roche Molecular Systems, Inc.
- COBAS® AmpliScreen HCV Test, v2.0 — Roche Molecular Systems, Inc.
- Procleix Ultrio Plus 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 e2fba1c0-68d1-4a3d-a79a-df41652cff1d 32 fields · synced Jun 9, 2026