Identity
- Trade Name
- ARCHITECT EUDAMEDFDA UDI
- Generic Name
- HIV1/HIV2 antigen/antibody IVD, control FDA UDI
- Device Name
- ARCHITECT Anti-CCP EUDAMEDARCHITECT HIV Ag/Ab Combo Controls FDA UDI
- Model / Reference
- 01P6574 EUDAMED2P36-10 FDA UDI
- Description
- ARCHITECT HIV Ag/Ab Combo Controls FDA UDI
Identifiers
- Catalog Number
- 02P3610 FDA UDI
- Primary DI / UDI-DI
- 00380740172459 EUDAMED00380740003883 FDA UDI
- Basic UDI-DI
- 038074ARP0165PB EUDAMED
- FDA Product Code
- MZF FDA UDI
- EMDN Code
- W01021112 ANTI-CYCLIC CITRULLINATED PEPTIDE EUDAMED
- GMDN Term
- HIV1/HIV2 antigen/antibody IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3956 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
No
FDA UDI
Category: HIV1/HIV2 antigen/antibody IVD, control
Architect by Abbott — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as HIV1/HIV2 antigen/antibody IVD, control.
- PreciControl HIV Gen II — Roche Diagnostics Corp. · Class I
- PreciControl HIV; HIV-2 + GrpO — Roche Diagnostics Corp. · Class I
- GS — Bio-Rad Laboratories · Class II
- LIAISON XL MUREX Control HIV Ab/Ag HT — Diasorin S.P.A
- PreciControl Release HIV Gen II — Roche Diagnostics Corp. · U
- ACCESS HIV Ag/Ab combo QC — Beckman Coulter, Inc. · Class I
- BioPlex® 2200 — Bio-Rad Laboratories · Class II
- ADVIA Centaur® CHIV QC — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Abbott
Sources (2)
- FDA UDI 3da493dc-0c4c-4f1e-96ad-b33ccdc71153 37 fields · synced Sep 30, 2026
- EUDAMED 4cdcb8e0-9632-4161-8d17-730679a4b2bc 61 fields · synced Sep 17, 2026