AccessGUDID - DEVICE: Methadone Metabolite 300 DAU Control, Level 1 Control (B0760197B0)

GUDID

Device Identifier (DI) Information

Brand Name: Methadone Metabolite 300 DAU Control, Level 1 Control
Version or Model: 0197b
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0197b
Company Name: LIN-ZHI INTERNATIONAL, INC.

Primary DI Number: B0760197B0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 840839190 *Terms of Use

Device Description: 5mL/bottle. Concentration: 225 ng/mL of EDDP.

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):	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?
43802	2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of the methadone metabolite 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	Drug Specific Control Materials

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 49e8910f-31a4-4f42-a9f2-0ce945b8a99d
Public Version Date: November 15, 2018
Public Version Number: 1
DI Record Publish Date: October 15, 2018