Device
For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. For informational and educational use. Dry format cards for ABO and/or RhD de...
Manufacturer
Eldon Biologicals A/S
Eldon Biologicals A/S
Model: 504-33v05
Catalog: 504-33
DI: 05713494002836
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. For informational and educational use. Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
832e45ec-68a0-4552-958a-d021e93ae8db
Distribution Status:
In Commercial Distribution
DUNS Number:
307910120
Device Count:
30
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
05713494000306
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05713494002836
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 45308
Name: ABO/Rh multiple blood grouping IVD, kit, agglutination
Definition:
A 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.
FDA Product Codes
KSZ
System, Test, Automated Blood Grouping And Antibody
Premarket Submissions
Submission Number:
K790282
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
5
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
37
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
5
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
37
Item #2 - Storage Handling Type:
Handling Environment Temperature