Anti-nDNA IgG IFA 96 Test

GUDID G5229024201

For the detection and titration of anti-native DNA antibodies in human sera

Hemagen Diagnostics, Inc.

Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
Primary Device IDG5229024201
NIH Device Record Key0cccf20e-b08a-4b33-a942-f4347b14c9f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-nDNA IgG IFA 96 Test
Version Model Number902420
Company DUNS147827216
Company NameHemagen 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 Usetrue
Lot Batchtrue
Serial Numberfalse
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

Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.com
Phone443 367 5500
Emailcustomerservice@hemagen.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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG5229024201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-13
Device Publish Date2023-10-05

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