AccessGUDID - DEVICE: IH-Card Control (07611969952212)

GUDID

Device Identifier (DI) Information

Brand Name: IH-Card Control
Version or Model: 813600100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 813600100
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 07611969952212
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: Optional card for the negative control in ABO and Rh typing; 12 cards of 6 microtubes

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):	Yes
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?
52705	Antisera matrix (non-reactive) IVD, control	A material consisting of antisera matrix but containing no active immunoglobulins that is intended be used as a negative control to verify the performance of an assay when testing a clinical specimen for red blood cell antigens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSF	Kit, Quality Control For Blood Banking Reagents

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK140139	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: e481c569-ff3b-4d7f-bc47-b119c692542f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 20, 2017