AccessGUDID - DEVICE: Biotestcell® A1 & B (07611969952663)

GUDID

Device Identifier (DI) Information

Brand Name: Biotestcell® A1 & B
Version or Model: 816057100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 816057100
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 07611969952663
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: Reagent Red Blood Cells; Biotestcell® A1 & B; 3.0 - 3.4%; pooled cells for reverse grouping by the tube test; 2x10ml

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):

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52691	Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination	A collection of specifically characterized reagent red blood cells that are supplied together and intended to be used in reverse ABO blood group testing of a clinical specimen using an agglutination method. Cells are selected due to their individual blood group specificities, which may include blood group antigens A1, A2, B, AB and/or O.	Active	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: adb0e6be-7574-4d7f-af06-55d80f059595
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2014