FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740002022
Brand
ARCHITECT
Company
Abbott GmbH
Model
1P65-01
Catalog number
01P6501
Device description
ARCHITECT Anti-CCP Calibrators
Published
2016-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE
JJYMulti-analyte controls, all kinds (assayed)
NHXANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1
NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)Immunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740002022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740002022003807400020223807400020220380740002022

GMDN Terms#

Term, Definition table
TermDefinition
Cyclic citrullinated peptide antibody (anti-CCP) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of antibodies to cyclic citrullinated peptide (CCP) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740199265Alinity06T790106T79012026-09-04
00380740199272Alinity06T791006T79102026-09-04
00380740208899Alinity06T792106T79212026-09-04
00380740208905Alinity06T793106T79312026-09-04
00380740223724Alinity06T793A06T793A2026-09-04
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01

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Primary DI, Brand, Company table
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10673486014136Teco Diagnostics TC Chemistry Calibrator ITECO DIAGNOSTICSJIX2026-08-25
00850011135556VALIDATELgc Clinical Diagnostics, Inc.JJY2026-07-07
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05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
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00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
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