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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Cyclic citrullinated peptide antibody (anti-CCP) IVD, control FDA UDI
Device Name
ARCHITECT Anti-CCP Controls FDA UDI
Model / Reference
1P65-10 FDA UDI
Description
ARCHITECT Anti-CCP Controls FDA UDI

Identifiers

Catalog Number
01P6510 FDA UDI
Primary DI / UDI-DI
00380740002039 FDA UDI
FDA Product Code
JIX FDA UDI
JJY FDA UDI
NHX FDA UDI
GMDN Term
Cyclic citrullinated peptide antibody (anti-CCP) IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
862.1660 FDA UDI
866.5775 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Category: Cyclic citrullinated peptide antibody (anti-CCP) IVD, control

Architect by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cyclic citrullinated peptide antibody (anti-CCP) IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott

Sources (1)

  • FDA UDI ca29ae59-a8af-43a1-b228-6ac9a5557cae 36 fields · synced Jun 8, 2026