AccessGUDID - DEVICE: ADVIA® Chemistry OP_2 Opiate

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry OP_2 Opiate_2 Reagents
Version or Model: 10378763
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10378763
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414568799
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Opiates - ADVIA Chem. - RGT - 4x190 tests

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?
55717	Opiate/opiate metabolite 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 opiate and/or opiate metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DJG	ENZYME IMMUNOASSAY, OPIATES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971596	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
Special Storage Condition, Specify: Do not freeze
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: 9fb1cf8a-3de9-4df9-a0db-85a471f3b403
Public Version Date: May 15, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2016