AccessGUDID - DEVICE: ADVIA® Chemistry METMTB Methadone Metabolite Reagents (00630414526904)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry METMTB Methadone Metabolite Reagents
Version or Model: 10335933
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5038055
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414526904
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: TBD

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?
59050	2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 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 the methadone metabolite 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DJR	ENZYME IMMUNOASSAY, METHADONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023617	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
Special Storage Condition, Specify: Do not freeze

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4958274c-d700-464f-b2da-80a0d04d73ba
Public Version Date: March 16, 2023
Public Version Number: 7
DI Record Publish Date: September 24, 2016