AccessGUDID - DEVICE: Quantum Blue® Reader (EBUHBIPOCTRABS0)

GUDID

Device Identifier (DI) Information

Brand Name: Quantum Blue® Reader
Version or Model: BI-POCTR-ABS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Bühlmann Laboratories AG

Primary DI Number: EBUHBIPOCTRABS0
Issuing Agency: HIBCC
Commercial Distribution End Date: January 12, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 481261006 *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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
42625	Photometric/spectroscopic immunoassay analyser IVD	An electrically-powered instrument intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card), after vehicle exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in the clinical specimen. The instrument uses photometry and/or light spectroscopy to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by healthcare professionals for rapid in vitro diagnostic measurements [e.g., lateral flow immunochromatographic (ICT) test] at the point-of-care or in the laboratory.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
Handling Environment Humidity: less than 70 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Storage Environment Temperature: between 15 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e28ce1d1-bcfa-4da6-8117-0b04d86b944b
Public Version Date: March 08, 2022
Public Version Number: 3
DI Record Publish Date: January 12, 2021