AccessGUDID - DEVICE: Anti-Human Globulin Anti-IgG Solidscreen II (07611969951437)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-Human Globulin Anti-IgG Solidscreen II
Version or Model: 806516100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 806516100
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 07611969951437
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: Anti-Human Globulin, Anti-IgG, Rabbit; for Solidscreen II with the TANGO instruments; 55ml

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):

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43763	Polyspecific antihuman globulin/complement IVD, antibody, solid-phase red blood cell adherence	One or multiple immunoglobulins capable of binding to all classes of human immunoglobulin antibodies and/or complement components when fixed to red blood cells. This solution is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human immunoglobulin and/or complement components, using a solid-phase red blood cell adherence method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: ff94660c-5186-4b67-8fe0-23d6e886b2c6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2014