FDA.reportPublic FDA data

CYFRA 21-1 EIA

Primary DI
17350066140135
Brand
CYFRA 21-1 EIA
Company
Fujirebio Diagnostics AB
Model
211-10
Published
2016-09-16
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
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
K100831000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100831000CYFRA 21-1 EIA MODEL 211-10Fujirebio Diagnostics,Inc.2011-05-26OVK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350066140135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1735006614013517350066140135

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4631857030info@fdab.com

Regulatory Flags#

DUNS number
357159631
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17350066140579AMH Control660-202019-04-25
17350066140524Mesothelin Control360-202019-03-28
17350066140531Lung Marker Control240-202019-03-28
17350066140043Tumor Marker Control108-202016-09-16
17350066140326HE4 EIA404-10US2016-09-16

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
00630414291345Atellica IM CYFRA 21-1Siemens Healthcare Diagnostics Inc.OVK2026-04-16
04015630940004Elecsys CYFRA 21-1Roche Diagnostics GmbHOVK2017-04-14
04015630934805Elecsys CYFRA 21-1Roche Diagnostics GmbHOVK2016-12-20