AccessGUDID - DEVICE: IH-Internal QC (07611969952342)

GUDID

Device Identifier (DI) Information

Brand Name: IH-Internal QC
Version or Model: 814172100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 07611969952342
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: For manual Quality Control testing, Set of 5x4 mL red cells in suspension (4 +/- 1%) and 3x3 mL sera (human, polyclonal)

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
45310	Multiple immunohaematology test IVD, control	A collection of reagent red blood cells and/or immunoglobulins directed at red blood cell antigens that are supplied together and intended to be used when testing a clinical specimen to verify the performance of multiple immunohaematological tests.	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 [?]
BK170064	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ab40f444-8c92-4850-92ec-8231eee897c6
Public Version Date: March 14, 2022
Public Version Number: 4
DI Record Publish Date: April 05, 2018