AccessGUDID - DEVICE: Solidscreen II-Control B (07611969951468)

GUDID

Device Identifier (DI) Information

Brand Name: Solidscreen II-Control B
Version or Model: 806519100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 806519100
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 07611969951468
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: Positive Control for Solidscreen II on TANGO instruments; 4ml

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:	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?
52703	Anti-Rh(D) antibody screen IVD, control	A material containing antibodies to Rh(D) red blood cell antigens [RH001] from the Rhesus system intended to be used in immunohaematological testing of a clinical specimen, to verify the performance of an antibody screening assay that is used for detecting red cell alloantibodies.	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 [?]
BK080013	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 77fb9675-003c-4c5f-8b60-bea346b745fa
Public Version Date: March 22, 2019
Public Version Number: 5
DI Record Publish Date: July 01, 2015