AccessGUDID - DEVICE: Emit® 2000 Quinidine Assay (00842768023293)

GUDID

Device Identifier (DI) Information

Brand Name: Emit® 2000 Quinidine Assay
Version or Model: 10445329
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4Q229
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768023293
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Emit® 2000 Quinidine Assay labeled with the Beckman Coulter® name

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
55359	Quinidine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug quinidine in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBZ	ENZYME IMMUNOASSAY, QUINIDINE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011605	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: 97b9e88c-29ee-4337-8677-e8f22da81a4f
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016