FDA.reportPublic FDA data

ELDON SCHOOL KIT SKA 2521-25

Primary DI
05713494002225
Brand
ELDON SCHOOL KIT SKA 2521-25
Company
Eldon Biologicals A/S
Model
614-08v04
Catalog number
614-08
Device description
For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO and /or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.
Published
2021-05-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSZSystem, Test, Automated Blood Grouping And Antibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSZSystem, Test, Automated Blood Grouping And AntibodyHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790282000ELDONCARDNordisk Infuser System1979-05-04KSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713494002225PrimaryGS10
05713494000313Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713494002225057134940022255713494002225
05713494000313057134940003135713494000313

GMDN Terms#

Term, Definition table
TermDefinition
ABO/Rh multiple blood grouping IVD, kit, agglutinationA collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen for a combination of multiple ABO system and Rh group red blood cell antigens, using an agglutination method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius37 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius37 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+4545931111eldoncard@eldoncard.com

Regulatory Flags#

DUNS number
307910120
Device count
50
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713494002829ELDON SCHOOL KIT SKA 2511-30504-32v07504-322026-05-19
05713494002836ELDON SCHOOL KIT SK 2511-30504-33v05504-332026-05-19
05713494002843ELDON SCHOOL KIT SKA 2521-25614-08v05614-082026-05-19
05713494002683ELDON MILITARY KIT MKA 2521-25614-26v01614-262024-07-05
05713494002690ONE MAN KIT OKA 2511-1504-37v01504-372024-07-05
05713494002638ELDON HOME KIT HKA 2511-1504-18v14504-182023-03-08
05713494000351DOCTOR'S KIT DKS RhD-25669-00v07669-002016-12-13
05713494002409ELDON HOME KIT HKA 2511-1504-18v13504-182022-11-28
05713494001792ELDON SCHOOL KIT SKA 2511-30504-32v05504-322020-11-04
05713494001952ELDON HOME KIT HKA 2511-2504-35v01504-352020-12-12
05713494001969ELDON HOME KIT HKA 2511-5504-36v01504-362020-12-12
05713494001761ELDON HOME KIT HKA 2511-1504-18v10504-182020-11-04
05713494001778ELDON HOME KIT HKA 2511-1504-16v11504-162020-11-04
05713494002270ELDON HOME KIT HKA 2511-1504-18v12504-182021-09-16
05713494001990ELDON HOME KIT HKA 2511-1504-18v11504-182021-04-27
05713494001754ELDON HOME KIT HKA 2511-1504-18v09504-182020-08-31
05713494000535ELDON HOME KIT HKA 2511-1504-15v08504-152019-10-23
05713494000528ELDON HOME KIT HKA 2511-1504-16v10504-162019-04-08
05713494000016ELDONBOX 2511-100 100 ELDONCARD 2511404-02v05404-022016-09-07
05713494000023ELDONBOX 2521-100 100 ELDONCARD 2521414-03v02414-032016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713494002829ELDON SCHOOL KIT SKA 2511-30Eldon Biologicals A/SKSZ2026-05-19
05713494002836ELDON SCHOOL KIT SK 2511-30Eldon Biologicals A/SKSZ2026-05-19
05713494002843ELDON SCHOOL KIT SKA 2521-25Eldon Biologicals A/SKSZ2026-05-19
05713494002683ELDON MILITARY KIT MKA 2521-25Eldon Biologicals A/SKSZ2024-07-05
05713494002690ONE MAN KIT OKA 2511-1Eldon Biologicals A/SKSZ2024-07-05
05713494002638ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2023-03-08
05713494002409ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2022-11-28
05713494002546ELDON SCHOOL KIT SKA 2521-25Eldon Biologicals A/SKSZ2022-10-04
10888234001553Capture-R SelectIMMUCOR, INC.KSZ2022-09-03
03610522055685IH-Card ABO NeutralBio-Rad Medical Diagnostics GmbHKSZ2022-03-09
05713494002287ELDON SCHOOL KIT SKA 2511-30Eldon Biologicals A/SKSZ2021-11-11
05713494002270ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2021-09-16
05713494001990ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2021-04-27
10758750032846ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSZ2021-04-07
03610522123919IH-Com V5.2Bio-Rad Medical Diagnostics GmbHKSZ2021-02-18
05713494001976ELDONBOX 2521-100 100 ELDONCARD 2521Eldon Biologicals A/SKSZ2021-02-04
05713494000313ELDONBOX 2521-100 100 ELDONCARD 2521Eldon Biologicals A/SKSZ2021-02-04
05713494001808ELDON SCHOOL KIT SK 2511-30Eldon Biologicals A/SKSZ2020-12-12
05713494001952ELDON HOME KIT HKA 2511-2Eldon Biologicals A/SKSZ2020-12-12
05713494001969ELDON HOME KIT HKA 2511-5Eldon Biologicals A/SKSZ2020-12-12
05713494000306ELDON HOME KIT HKA 2511-5Eldon Biologicals A/SKSZ2020-12-12
05060496770066Ortho ConnectBIOMEDICAL DATA SOLUTIONS LIMITEDKSZ2020-11-18
08437014205008DG Gel 8 NeutralDIAGNOSTIC GRIFOLS SAKSZ2020-11-16
05713494001785ELDONBOX 2511-100 100 ELDONCARD 2511Eldon Biologicals A/SKSZ2020-11-04
05713494001792ELDON SCHOOL KIT SKA 2511-30Eldon Biologicals A/SKSZ2020-11-04
05713494001761ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2020-11-04
05713494001778ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2020-11-04
05713494001754ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2020-08-31
14987666543344PK7400Beckman Coulter, Inc.KSZ2020-07-06
08437014205619DG Reader NetDIAGNOSTIC GRIFOLS SAKSZ2019-11-27