AccessGUDID - DEVICE: B.R.A.H.M.S Basiskit LIA (04260157633711)

GUDID

Device Identifier (DI) Information

Brand Name: B.R.A.H.M.S Basiskit LIA
Version or Model: 371.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: B.R.A.H.M.S GmbH

Primary DI Number: 04260157633711
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 343844205 *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:	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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Chemiluminescent immunoassay signal generation kit IVD	A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an immunoassay on a clinical specimen. The kit is typically used in conjunction with luminescent-labelled antibodies or antigens of known characterization and may also include reference material to optimise and verify performance of the luminometer instrument.

FDA Product Code

[?]

Product Code	Product Code Name
NTM	Antigen, Inflammatory Response Marker, Sepsis

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dc8af346-7ff0-4239-8c6c-7022ee5a99e9
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 17, 2016