FDA.reportPublic FDA data

ELDON HOME KIT HKA 2511-5

Primary DI
05713494000306
Brand
ELDON HOME KIT HKA 2511-5
Company
Eldon Biologicals A/S
Model
504-36v01
Catalog number
504-36
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
2020-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
05713494001785PrimaryGS10
05713494001792PrimaryGS10
05713494001808PrimaryGS10
05713494001952PrimaryGS10
05713494001969PrimaryGS10
05713494002287PrimaryGS10
05713494000306Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713494001785057134940017855713494001785
05713494001792057134940017925713494001792
05713494001808057134940018085713494001808
05713494001952057134940019525713494001952
05713494001969057134940019695713494001969
05713494002287057134940022875713494002287
05713494000306057134940003065713494000306

GMDN Terms#

Term, Definition table
TermDefinition
ABO/Rh(D) 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 one or multiple ABO system and/or Rh (D) (RH001) 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
307910120
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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
05713494002225ELDON SCHOOL KIT SKA 2521-25614-08v04614-082021-05-31
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

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
05713494002225ELDON SCHOOL KIT SKA 2521-25Eldon Biologicals A/SKSZ2021-05-31
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
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