AccessGUDID - DEVICE: OLO Control Kit (B787OCK10)

GUDID

Device Identifier (DI) Information

Brand Name: OLO Control Kit
Version or Model: OCK1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: S.D. SIGHT DIAGNOSTICS LTD

Primary DI Number: B787OCK10
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: An in vitro diagnostic control reagent designed to monitor values on the Sight OLO multi-parameter hematology analyser.

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55866	Full blood count IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCN	Control, Cell Counter, Normal And Abnormal

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 Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4374b0f8-f627-438f-90ab-9ac8f0801956
Public Version Date: November 14, 2024
Public Version Number: 2
DI Record Publish Date: May 04, 2020