Whole Blood Primer 2700351

GUDID 00847817010606

Whole Blood Primer

BIO-RAD LABORATORIES, INC.

Glycated haemoglobin (HbA1c) IVD, reagent
Primary Device ID00847817010606
NIH Device Record Key597ed0b7-bd59-455a-9b98-72e781b6c05a
Commercial Distribution StatusIn Commercial Distribution
Brand NameWhole Blood Primer
Version Model Number270-0351
Catalog Number2700351
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
Phone+1(800)224-6723
Emaildiagcs@bio-rad.com
Phone+1(800)224-6723
Emaildiagcs@bio-rad.com
Phone+1(800)224-6723
Emaildiagcs@bio-rad.com
Phone+1(800)224-6723
Emaildiagcs@bio-rad.com
Phone+1(800)224-6723
Emaildiagcs@bio-rad.com
Phone+1(800)224-6723
Emaildiagcs@bio-rad.com
Phone+1(800)224-6723
Emaildiagcs@bio-rad.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
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
GS100847817010606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPDHEMOGLOBIN A2 QUANTITATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-23
Device Publish Date2016-09-12

On-Brand Devices [Whole Blood Primer]

00847817010613Whole Blood Primer
00847817010606Whole Blood Primer
00847817003400Whole Blood Primer

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