Autostat II Anti-Jo-1

GUDID 00816879020335

96 well ELISA for the detection of Anti-Jo-1 antibodies in human serum

HYCOR BIOMEDICAL LLC

Jo-1 antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00816879020335
NIH Device Record Key6aea6c75-0618-4b33-bab4-376a39784520
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutostat II Anti-Jo-1
Version Model NumberFGA33
Company DUNS010558476
Company NameHYCOR BIOMEDICAL LLC
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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816879020335 [Primary]

FDA Product Code

LLLExtractable Antinuclear Antibody, Antigen And Control

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 Date2016-09-26

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