AccessGUDID - DEVICE: Sirius 2 Tube Luminometer (B17384018010)

GUDID

Device Identifier (DI) Information

Brand Name: Sirius 2 Tube Luminometer
Version or Model: 84018-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8401801
Company Name: Spectral Medical Inc

Primary DI Number: B17384018010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 248909939 *Terms of Use

Device Description: The Sirius 2 Tube Luminometer is a highly sensitive and compact stand-alone single tube luminometer. The touchscreen on the control unit is all that is needed to operate the luminometer. Menus and parameters for functions that are not automated, are selected via the touchscreen on the control unit. The display shows the menu items, the actions performed, and the user prompts. The luminometer is capable of reading USB keys. Measurement protocols may be saved on USB keys. During a procedure, the user is prompted step-by-step to place the required tubes into the instrument for measurement. This ensures the standardization of the measurement process. The Sirius 2 is designed for the detection of chemi- and bioluminescence.

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:	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?
56676	Multiple clinical chemistry analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Humidity: between 0 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -25 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 99aab42b-0177-4a79-a321-69bb9f2c13c9
Public Version Date: March 31, 2025
Public Version Number: 1
DI Record Publish Date: March 21, 2025