AccessGUDID - DEVICE: QUANTA Flash® HMGCR Reagents (08426950793182)

GUDID

Device Identifier (DI) Information

Brand Name: QUANTA Flash® HMGCR Reagents
Version or Model: 701333
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INOVA DIAGNOSTICS, INC.

Primary DI Number: 08426950793182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 188354831 *Terms of Use

Device Description: 1 QUANTA Flash HMGCR Reagent Cartridge. 1 Resuspension Buffer. 1 Transfer pipette.

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?
63068	3-Hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) in a clinical specimen, using a chemiluminescent immunoassay method. It is used to aid the diagnosis of immune-mediated necrotizing myopathy (IMNM).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLL	Extractable Antinuclear Antibody, Antigen And Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180975	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: 9171a5e6-02ee-48e2-9d5c-2c7f4d331117
Public Version Date: December 03, 2018
Public Version Number: 1
DI Record Publish Date: October 31, 2018