AccessGUDID - DEVICE: OLO CBC Test Kit (B787TK10)

GUDID

Device Identifier (DI) Information

Brand Name: OLO CBC Test Kit
Version or Model: TK1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: S.D. SIGHT DIAGNOSTICS LTD

Primary DI Number: B787TK10
Issuing Agency: HIBCC
Commercial Distribution End Date: September 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 534144402 *Terms of Use

Device Description: A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

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:	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?
55854	Full blood count IVD, kit, cell count	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, Differential Cell

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
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 18 and 26 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 29b0382c-198c-41cf-b455-c721404111f0
Public Version Date: November 14, 2024
Public Version Number: 3
DI Record Publish Date: February 09, 2020