AccessGUDID - DEVICE: Elecsys Vitamin D total III (07613336184615)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys Vitamin D total III
Version or Model: 09038078160
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09038078160
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336184615
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: Vitamin D total G3 Elecsys cobas e 100

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:	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?
60922	Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen, using a chemiluminescent immunoassay.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRG	SYSTEM, TEST, VITAMIN D

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210901	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c46d6eea-510b-48b8-b631-a27880d538bd
Public Version Date: December 15, 2021
Public Version Number: 1
DI Record Publish Date: December 07, 2021