Immuno-Brite Fluorospheres 6603473

GUDID 15099590536985

IMMUNO-BRITE Standards Kit

Beckman Coulter, Inc.

Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent
Primary Device ID15099590536985
NIH Device Record Key6e31e218-86a7-495c-91fb-0c2b2a019d0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmuno-Brite Fluorospheres
Version Model Number6603473
Catalog Number6603473
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590536985 [Primary]

FDA Product Code

PPMGeneral Purpose Reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-15

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