Immco Diagnostics, Inc 5152A

GUDID 00845714002427

B2GP1 IgA ELISA

IMMCO DIAGNOSTICS, INC.

Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00845714002427
NIH Device Record Keya83276c5-a779-4676-b82e-22d1d6d955b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmco Diagnostics, Inc
Version Model Number5152A
Catalog Number5152A
Company DUNS079935300
Company NameIMMCO DIAGNOSTICS, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-537-8378
Emailinfo@immco.com
Phone1-800-537-8378
Emailinfo@immco.com
Phone1-800-537-8378
Emailinfo@immco.com
Phone1-800-537-8378
Emailinfo@immco.com
Phone1-800-537-8378
Emailinfo@immco.com
Phone1-800-537-8378
Emailinfo@immco.com
Phone1-800-537-8378
Emailinfo@immco.com
Phone1-800-537-8378
Emailinfo@immco.com
Phone1-800-537-8378
Emailinfo@immco.com
Phone1-800-537-8378
Emailinfo@immco.com
Phone1-800-537-8378
Emailinfo@immco.com
Phone1-800-537-8378
Emailinfo@immco.com
Phone1-800-537-8378
Emailinfo@immco.com

Device Dimensions

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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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
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
GS100845714002427 [Primary]

FDA Product Code

MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-07-11

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