Bromelin for Erytype 806210100

GUDID 07611969951307

Red Blood Cell Diluent for TANGO instruments, 10x10 ml

Bio-Rad Medical Diagnostics GmbH

Bromelin immunohaematology reagent IVD
Primary Device ID07611969951307
NIH Device Record Keyab4467f3-d462-49b5-bf27-e7ec21eed877
Commercial Distribution StatusIn Commercial Distribution
Brand NameBromelin for Erytype
Version Model Number806210100
Catalog Number806210100
Company DUNS312576506
Company NameBio-Rad Medical Diagnostics GmbH
Device Count1
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

Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107611969951307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSZSystem, Test, Automated Blood Grouping And Antibody

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-01

On-Brand Devices [Bromelin for Erytype]

07611969965755Red Blood Cell Diluent for TANGO instruments, 10x10 mL
07611969951307Red Blood Cell Diluent for TANGO instruments, 10x10 ml

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