CliniMACS PBS/EDTA Buffer 1L 700-25

GUDID 04049934004674

CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.

Miltenyi Biotec GmbH

Magnetic cell separation system buffered saline solution
Primary Device ID04049934004674
NIH Device Record Keyc0e16d0f-fdfc-442f-932e-a2e5c988860b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCliniMACS PBS/EDTA Buffer 1L
Version Model Number70026
Catalog Number700-25
Company DUNS327036034
Company NameMiltenyi Biotec GmbH
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104049934001666 [Unit of Use]
GS104049934004674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVGMagnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-31
Device Publish Date2016-07-22

On-Brand Devices [CliniMACS PBS/EDTA Buffer 1L]

04049934004672CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of t
04049934004674CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of t

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.