AccessGUDID - DEVICE: Immunalysis Corporation (00840937108703)

GUDID

Device Identifier (DI) Information

Brand Name: Immunalysis Corporation
Version or Model: 618UR-0500EX
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: IMMUNALYSIS CORPORATION

Primary DI Number: 00840937108703
Issuing Agency: GS1
Commercial Distribution End Date: September 20, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 080589004 *Terms of Use

Device Description: Immunalysis Corporation SEFRIA Fentanyl Urine Kit 500 mL Export

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):	No
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?
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
No Product Codes

FDA Premarket Submission

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

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: 68bb7e7c-593e-4d6d-8746-a2a737c5fddb
Public Version Date: December 19, 2024
Public Version Number: 5
DI Record Publish Date: September 13, 2016