Anti-Cardiolipin-A ELISA 35-CAAHU-E01

GUDID B24235CAAHUE010

The Anti-Cardiolipin-A ELISA is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human β2-glycoprotein I (β2-GPI) fo

AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device IDB24235CAAHUE010
NIH Device Record Keyb6ec934d-fbae-45cc-9f80-daeec2b66ec9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-Cardiolipin-A ELISA
Version Model Number35-CAAHU-E01
Catalog Number35-CAAHU-E01
Company DUNS784143778
Company NameAMERICAN LABORATORY PRODUCTS COMPANY, LTD.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.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
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
HIBCCB24235CAAHUE010 [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 Date2017-08-28

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