FDA.reportPublic FDA data

Elecsys Calcitonin

Primary DI
07613336171509
Brand
Elecsys Calcitonin
Company
Roche Diagnostics GmbH
Model
09005676190
Catalog number
09005676190
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JKRRADIOIMMUNOASSAY, CALCITONIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKRRadioimmunoassay, CalcitoninClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252431000Elecsys CalcitoninRoche Diagnostics GmbH2026-04-24JKR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336171509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336171509076133361715097613336171509

GMDN Terms#

Term, Definition table
TermDefinition
Calcitonin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of calcitonin in a clinical specimen, using a chemiluminescent immunoassay method.

Regulatory Flags#

DUNS number
315028860
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
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
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336188064Elecsys CalcitoninRoche Diagnostics GmbHJKR2026-06-01
00816870023694Calcitonin AccuLite CLIA Test System -192 WellsMONOBIND, INC.JKR2024-09-13
00816870023700Calcitonin AccuLite CLIA Test System - 96 WellsMONOBIND, INC.JKR2024-09-13
00816870023717Calcitonin AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JKR2024-09-13
00816870023724Calcitonin AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JKR2024-09-13
04048474036480Calcitonin ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKR2023-08-31
00083059070248Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.JKR2020-07-01
00630414284736ADVIA Centaur CalcitoninSiemens Healthcare Diagnostics Inc.JKR2019-07-05
00630414284743Atellica IM CalcitoninSiemens Healthcare Diagnostics Inc.JKR2019-07-05
00840239036483Calcitonin ELISADRG International IncJKR2019-06-10
00850002253153Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.JKR2019-05-20
B24221CALHUE010Calcitonin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKR2017-08-03
04015630940158Elecsys CalcitoninRoche Diagnostics GmbHJKR2017-04-21
08305900070248Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.JKR2016-12-07
00630414953120IMMULITE® Systems CONTROL CalcitoninSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKR2016-09-24
00630414953618IMMULITE / IMMULITE® 1000 Systems CAL Calcitonin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKR2016-09-24
00630414961156IMMULITE® 2000 Systems CAL CalcitoninSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKR2016-09-24
00630414963730IMMULITE / IMMULITE® 1000 Systems CAL CalcitoninSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKR2016-09-24
04015630934799Elecsys Calcitonin ImmunoassayRoche Diagnostics GmbHJKR2016-09-20
30014613333937MicroVueQUIDEL CORPORATIONJKR2016-09-15