FDA.reportPublic FDA data

DOCTOR'S KIT DKS RhD-25

Primary DI
05713494000351
Brand
DOCTOR'S KIT DKS RhD-25
Company
Eldon Biologicals A/S
Model
669-00v07
Catalog number
669-00
Device description
For 75 RhD blood group determinations. Not for use for screening purposes prior to transfusion. Dry format cards for RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.
Published
2016-12-13
Public version status
Update
Distribution status
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
05713494000351PrimaryGS10
05713494000320Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713494000351057134940003515713494000351
05713494000320057134940003205713494000320

GMDN Terms#

Term, Definition table
TermDefinition
Anti-Rh(D) red blood cell grouping IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for Rh(D) [RH001] red blood cell antigens from the rhesus system, 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
75
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
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
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
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
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