AccessGUDID - DEVICE: Spinalscopics Control Level 2 Set 3x3mL (00896863002097)

GUDID

Device Identifier (DI) Information

Brand Name: Spinalscopics Control Level 2 Set 3x3mL
Version or Model: 1462-31
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1462-31
Company Name: QUANTIMETRIX CORPORATION

Primary DI Number: 00896863002097
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010717890 *Terms of Use

Device Description: Spinalscopics Spinal Fluid Cell Count Control is intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient CSF samples. Total cell counts are performed in a counting chamber with undiluted CSF. They are supplied in two levels, 3x3mL bottles per level per box. The controls are ready-to-use liquid, requiring no reconstitution or dilution. They are prepared in a human protein matrix fortified to target levels with purified chemicals and stabilized human red and white blood cells. Preservatives have been added to inhibit microbial growth.

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?
56225	White blood cell 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 white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen.	Active	false
55868	Red blood cell 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 red blood cell (erythrocyte) count and/or the calculation of intermediate red cell parameters in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)
JPK	Mixture, Hematology Quality Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970862	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c663fa27-c617-4ec0-8308-be16e0e64558
Public Version Date: October 29, 2018
Public Version Number: 1
DI Record Publish Date: September 26, 2018