AccessGUDID - DEVICE: NOVA Lite® DAPI ANA Kit (08426950621843)

GUDID

Device Identifier (DI) Information

Brand Name: NOVA Lite® DAPI ANA Kit
Version or Model: 704320
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INOVA DIAGNOSTICS, INC.

Primary DI Number: 08426950621843
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 188354831 *Terms of Use

Device Description: 1. 20x ANA Hep- 2 -QR Slide (12 well) 2. 1x 0.5mL IFA System Negative Control 3. 1x 15mL FITC IgG Conjugate with DAPI 4. 1x 7mL Mounting Medium 5. 2x 25mL PBS II Concentrate (40x) 6 .1x Coverlips, 20 each 7. 1x 0.5mL ANA Titratable Pattern

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
54808	Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150155	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4431b948-bad2-4893-8b3a-13eed0499b66
Public Version Date: September 27, 2019
Public Version Number: 4
DI Record Publish Date: August 31, 2016