AccessGUDID - DEVICE: Advanced Instruments GloCyte® Total Nucleated Cell Test Reagent Kit (10816068020228)

GUDID

Device Identifier (DI) Information

Brand Name: Advanced Instruments GloCyte® Total Nucleated Cell Test Reagent Kit
Version or Model: 111012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 111012
Company Name: ADVANCED INSTRUMENTS, INC.

Primary DI Number: 10816068020228
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 125006353 *Terms of Use

Device Description: For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Total Nucleated Cell Reagent Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains three 1.8mL vials of Total Nucleated Cell (TNC) Reagent.

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:	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?
59104	Nuclear fast red solution IVD	A nuclear fast red solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GKL	Counter, Cell, Automated (Particle Counter)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152776	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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ea3b9f88-9ae3-4bed-9681-683cdd2058f5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016