DOCTOR'S KIT DKS RhD-25 669-00

GUDID 05713494000351

For 75 RhD blood group determinations. Not for use for screening purposes prior to transfusion. Dry format cards for RhD determination for the groupin

Eldon Biologicals A/S

Anti-Rh(D) red blood cell grouping IVD, antibody
Primary Device ID05713494000351
NIH Device Record Key62a6323b-d9c0-4dc4-8585-baee4dae103d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDOCTOR'S KIT DKS RhD-25
Version Model Number669-00v07
Catalog Number669-00
Company DUNS307910120
Company NameEldon Biologicals A/S
Device Count75
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105713494000320 [Unit of Use]
GS105713494000351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSZSystem, Test, Automated Blood Grouping And Antibody

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-13