Autoimmune EIA 425-2140

GUDID 00847817018275

Autoimmune EIA Anti-Phosphatidylserine IgM Test Kit

BIO-RAD LABORATORIES, INC.

Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00847817018275
NIH Device Record Keyebaa0d8b-618b-4c84-a234-8fad36a124ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoimmune EIA
Version Model Number425-2140
Catalog Number425-2140
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 Kittrue
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
GS100847817018275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIDSYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL

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 Date2016-09-12

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00847817022388Autoimmune EIA ENA Plus Screening test
00847817022364Autoimmune EIA Anti-dsDNA Test
00847817022340Autoimmune EIA Anti-Centromere Test
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00847817018220Autoimmune EIA Anti-Cardiolipin IgA Test Kit
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00847817006913Autoimmune EIA Stop Solution, 15 mL

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