Hemoglobin Variants System 2500002

GUDID 00847817007064

Hemoglobin Variants System Elution Buffer 2

BIO-RAD LABORATORIES, INC.

Inherited haemoglobinopathy IVD, reagent
Primary Device ID00847817007064
NIH Device Record Key62c40989-f315-42e4-9148-16e34dd59e78
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemoglobin Variants System
Version Model Number250-0002
Catalog Number2500002
Company DUNS132528295
Company NameBIO-RAD LABORATORIES, INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)224-6723
Emaildiagcs@bio-rad.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847817007064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKAABNORMAL HEMOGLOBIN QUANTITATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-02
Device Publish Date2020-06-24

On-Brand Devices [Hemoglobin Variants System]

00847817007187Hemoglobin Variants System Control Set
00847817007170Hemoglobin Variants System Calibrator Set
00847817007156Hemoglobin Variants System Reorder Pack
00847817007071Hemoglobin Variants System Wash Solution
00847817007064Hemoglobin Variants System Elution Buffer 2
00847817007057Hemoglobin Variants System Elution Buffer 1
00847817006791Hemoglobin Variants System Cation Exchange Mini-Columns
00847817007163Hemoglobin Variants System Cation Exchange Mini-Columns

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