AccessGUDID - DEVICE: Dynabeads™ HLA Cell Prep™ II (10190302006835)

GUDID

Device Identifier (DI) Information

Brand Name: Dynabeads™ HLA Cell Prep™ II
Version or Model: 21903
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THERMO FISHER SCIENTIFIC BALTICS UAB

Primary DI Number: 10190302006835
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 644884074 *Terms of Use

Device Description: DYNABEADS HLA CELL PREP II

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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
56611	B lymphocyte magnetic separation reagent IVD	A substance or reactant intended to be used on clinical specimens for the isolation of B-lymphocytes from a white cell preparation using magnetic beads to achieve component separation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCF	LYMPHOCYTE SEPARATION MEDIUM

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: a420dc70-a478-4842-a316-b764cd82690d
Public Version Date: June 04, 2024
Public Version Number: 2
DI Record Publish Date: July 03, 2018