AccessGUDID - DEVICE: QUANTA Lite® ACA IgM III (08426950485988)

GUDID

Device Identifier (DI) Information

Brand Name: QUANTA Lite® ACA IgM III
Version or Model: 708630
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INOVA DIAGNOSTICS, INC.

Primary DI Number: 08426950485988
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 188354831 *Terms of Use

Device Description: 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ACA Negative Control 3. 1x 1.2mL prediluted ACA IgM III Control 4. 1x 1.2mL prediluted ACA IgM III Calibrator A 5. 1x 1.2mL prediluted ACA IgM III Calibrator B 6. 1x 1.2mL prediluted ACA IgM III Calibrator C 7. 1x 1.2mL prediluted ACA IgM III Calibrator D 8. 1x 1.2mL prediluted ACA IgM III Calibrator E 9. 1x 50mL ACA III Sample Diluent 10. 1x 50mL ACA III PBS Concentrate, 20x concentrate 11. 1x 10mL HRP IgM Conjugate, (goat), anti-human IgM 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

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?
54870	Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to cardiolipin in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MID	System, Test, Anticardiolipin Immunological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K946385	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: 108c4f5c-1e7a-48e1-9930-036810d0414d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016