AccessGUDID - DEVICE: DailyChek QC Kit (00858400005084)

GUDID

Device Identifier (DI) Information

Brand Name: DailyChek QC Kit
Version or Model: 510395
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMERICAN NATIONAL RED CROSS

Primary DI Number: 00858400005084
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 003255213 *Terms of Use

Device Description: Blood Bank kit used to perform quality control testing of reverse grouping and screening cell reagent 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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
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 [?]
BK120042	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 1 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 47dc9566-5d5c-4f0e-9550-8d468d166625
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 21, 2016