AccessGUDID - DEVICE: QUANTA Lite® β2GPI IgA ELISA Bulk Pack (08426950594659)

GUDID

Device Identifier (DI) Information

Brand Name: QUANTA Lite® β2GPI IgA ELISA Bulk Pack
Version or Model: 708675.10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INOVA DIAGNOSTICS, INC.

Primary DI Number: 08426950594659
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 188354831 *Terms of Use

Device Description: 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgA ELISA Control 4. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A 5. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B 6. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C 7. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D 8. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E 9. 9x 50mL HRP Sample Diluent 10. 10x 25mL HRP Wash Concentrate, 40x concentrate 11. 10x 10mL HRP IgA Conjugate, (goat), anti-human IgA 12. 10x 10mL TMB Chromogen 13. 10x 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?
54879	Beta-2-glycoprotein I 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 beta-2-glycoprotein I in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973006	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: 2f92b8d2-8f26-4ef0-93e2-602f29445a20
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016