FDA.reportPublic FDA data

Atellica IM CYFRA 21-1

Primary DI
00630414291345
Brand
Atellica IM CYFRA 21-1
Company
Siemens Healthcare Diagnostics Inc.
Model
11354591
Catalog number
11354591
Device description
CYFRA 21-1 (CYFRA) Atellica IM - RGT 100T
Published
2026-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVKcytokeratin fragments 21-1 eia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVKCytokeratin Fragments 21-1 Eia KitImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250925000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250925000ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc.2025-12-16OVK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414291345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414291345006304142913456304142913450630414291345

GMDN Terms#

Term, Definition table
TermDefinition
Cytokeratin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple cytokeratin subtype(s) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31
00630414293752Atellica IM SHBG11206215112062152020-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)Siemens Healthcare Diagnostics Inc.OVK2026-04-16
04015630940004Elecsys CYFRA 21-1Roche Diagnostics GmbHOVK2017-04-14
04015630934805Elecsys CYFRA 21-1Roche Diagnostics GmbHOVK2016-12-20
17350066140135CYFRA 21-1 EIAFujirebio Diagnostics ABOVK2016-09-16