AccessGUDID - DEVICE: IH-Card ABO Neutral (03610522055685)

GUDID

Device Identifier (DI) Information

Brand Name: IH-Card ABO Neutral
Version or Model: 12008722
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12008722
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 03610522055685
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52710	Column agglutination IVD	A non-reactive suspension medium containing beaded particles, with or without added agglutination enhancing reagents (e.g., LISS, enzymes), presented as a a set of gels or solid phase columns and intended to be used in testing a clinical specimen for red blood cell antigens and/or antibodies, using a column agglutination technique.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSZ	System, Test, Automated Blood Grouping And Antibody

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK210625	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cc66ca6a-b6c2-4fc1-9938-ca0481c62616
Public Version Date: March 17, 2022
Public Version Number: 1
DI Record Publish Date: March 09, 2022