Identity
- Trade Name
- Procleix FDA UDI
- Generic Name
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products. FDA UDI
- Model / Reference
- Ultrio 1K FDA UDI
- Description
- FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products. FDA UDI
Identifiers
- Catalog Number
- 301103C FDA UDI
- Primary DI / UDI-DI
- 15420045500549 FDA UDI
- GMDN Term
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Commercial Distribution
- Not 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
No
FDA UDI
Procleix by Hologic, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Hologic, Inc.
Sources (1)
- FDA UDI 56a5deba-6015-40f7-bec9-2dda78f9d440 35 fields · synced Jun 1, 2026