AccessGUDID - DEVICE: Cortisol Saliva Luminescence Immunoassay (04049325007734)

GUDID

Device Identifier (DI) Information

Brand Name: Cortisol Saliva Luminescence Immunoassay
Version or Model: RE62119
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RE62119
Company Name: IBL International GmbH

Primary DI Number: 04049325007734
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312694785 *Terms of Use

Device Description: Cortisol Saliva Luminescence Immunoassay Assay Kit - 10x96 Determinations

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):	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?
62263	Free cortisol IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free cortisol in a clinical specimen, using a chemiluminescent immunoassay method. It is used as an aid in the diagnosis and treatment of adrenal disorders.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHG	Enzyme Immunoassay, Cortisol, Salivary

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: da6c2ad5-dd6f-49ec-9e13-957f2b87f76b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016