AccessGUDID - DEVICE: Total Protein Gen2 (04015630918928)

GUDID

Device Identifier (DI) Information

Brand Name: Total Protein Gen2
Version or Model: 3183734190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3183734190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630918928
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

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:	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?
53985	Total protein IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of total protein in a clinical specimen, using an enzyme spectrophotometry method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CEK	BIURET (COLORIMETRIC), TOTAL PROTEIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K951595	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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d1ca37e-94e9-4073-b8e4-dfe213f7173f
Public Version Date: October 12, 2020
Public Version Number: 3
DI Record Publish Date: September 20, 2016