AccessGUDID - DEVICE: B.R.A.H.M.S KRYPTOR compact SOLUTION 4 (04260157633247)

GUDID

Device Identifier (DI) Information

Brand Name: B.R.A.H.M.S KRYPTOR compact SOLUTION 4
Version or Model: 89984
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: B.R.A.H.M.S GmbH

Primary DI Number: 04260157633247
Issuing Agency: GS1
Commercial Distribution End Date:
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Fluorescent immunoassay analyser IVD, laboratory, automated	A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

GMDN Preferred Term Name

GMDN Definition

Fluorescent immunoassay analyser IVD, laboratory, automated

A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

FDA Product Code

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Product Code	Product Code Name
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN150009	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: 0ff0d31b-a64d-4098-b1d7-7bce63db54e1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 17, 2016