FDA.reportPublic FDA data

Elecsys Anti-CCP

Primary DI
04015630940370
Brand
Elecsys Anti-CCP
Company
Roche Diagnostics GmbH
Model
07251670190
Catalog number
07251670190
Published
2017-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DHXSYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHXSystem, Test, Carcinoembryonic AntigenImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081338000ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCPRoche Diagnostics2008-09-11NHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630940370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630940370040156309403704015630940370

GMDN Terms#

Term, Definition table
TermDefinition
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to cyclic citrullinated peptide antibody (CCP) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278620873MACGe Medical Systems Information Technologies, Inc.DHX2026-03-31
07613336218358Elecsys CEARoche Diagnostics GmbHDHX2025-11-07
10758750034307VITROSORTHO CLINICAL DIAGNOSTICSDHX2024-01-20
20758750034304VITROSORTHO CLINICAL DIAGNOSTICSDHX2024-01-20
00630414293585Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2020-05-31
00630414294131Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2020-05-31
04560189212244AIA-PACK CEA Calibration Verification Test SetTOSOH CORPORATIONDHX2019-07-25
14560189212241AIA-PACK CEA Calibration Verification Test SetTOSOH CORPORATIONDHX2019-07-25
00816870020532CEA AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870020549CEA AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870020556CEA-NG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870020563CEA-NG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870022215CEA AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870022222CEA AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870022239CEA-NG AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870022246Monobind AccuLite CEA Next Generation CLIA Kit - 192 WellsMONOBIND, INC.DHX2019-02-11
00380740130831AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130848AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130855AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130862AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00630414598505Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2018-02-06
00630414598536Atellica IM CEA MCMSiemens Healthcare Diagnostics Inc.DHX2018-02-06
00630414598529Atellica IM CEA DILSiemens Healthcare Diagnostics Inc.DHX2017-12-27
00630414598512Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2017-12-22
04015630939664Elecsys CEARoche Diagnostics GmbHDHX2017-04-14
14560189210780ST AIA-PACK CEATOSOH CORPORATIONDHX2016-09-24
04560189211780AIA-PACK CEA Sample Diluting SolutionTOSOH CORPORATIONDHX2016-09-24
00842768019920Dimension Vista® Flex® reagent cartridge CEASiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414126302ADVIA Centaur® CEA MCMSiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414175317ADVIA Centaur® CEA DiluentSiemens Healthcare Diagnostics Inc.DHX2016-09-24