AccessGUDID - DEVICE: T4 Calibrators (04015630916023)

GUDID

Device Identifier (DI) Information

Brand Name: T4 Calibrators
Version or Model: 20762016322
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20762016322
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630916023
Issuing Agency: GS1
Commercial Distribution End Date: December 18, 2018
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?
30504	Multiple human hormone IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of multiple human hormones in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DLJ	CALIBRATORS, DRUG SPECIFIC

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ca42242-6a39-4ce1-ad8e-21dfff2713de
Public Version Date: November 11, 2020
Public Version Number: 4
DI Record Publish Date: September 20, 2016