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

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04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
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07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
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07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

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Primary DI, Brand, Company table
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00630414293585Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2020-05-31
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00816870020532CEA AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
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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
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00630414598505Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2018-02-06
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00630414598529Atellica IM CEA DILSiemens Healthcare Diagnostics Inc.DHX2017-12-27
00630414598512Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2017-12-22
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14560189210780ST AIA-PACK CEATOSOH CORPORATIONDHX2016-09-24
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