CLA® Allergen-Specific IgE Assay - Northeastern Inhalant Panel 84504

GUDID 00813382010112

KIT, Northeastern Inhalant

HITACHI CHEMICAL DIAGNOSTICS, INC.

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
Primary Device ID00813382010112
NIH Device Record Keybcb42bdf-92a0-4c97-b1d6-cd1c06148c18
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLA® Allergen-Specific IgE Assay - Northeastern Inhalant Panel
Version Model Number84504
Catalog Number84504
Company DUNS102113867
Company NameHITACHI CHEMICAL DIAGNOSTICS, INC.
Device Count1
DM Exempttrue
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

Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100813382010112 [Primary]

FDA Product Code

DHBSYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

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 Date2016-08-19

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