ANA PLATE 196AN-BPU-ED

GUDID 03610520569184

ANA PLATE, 12X8 WELLS, BULK PACK, UNLABELED

BIO-RAD LABORATORIES, INC.

Multiple antinuclear antibody (ANA) screening IVD, reagent
Primary Device ID03610520569184
NIH Device Record Keye14df349-cddc-4e99-8109-52d2165eb8cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameANA PLATE
Version Model Number196AN-BPU-ED
Catalog Number196AN-BPU-ED
Company DUNS884513334
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 Usetrue
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
EmailTechSupport.USSD@bio-rad.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103610520569184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKJANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-23
Device Publish Date2016-09-12

On-Brand Devices [ANA PLATE]

03610520569184ANA PLATE, 12X8 WELLS, BULK PACK, UNLABELED
03610520547663ANA PLATE, 12X8 WELLS, BULK PACK, UNLABELED

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