AccessGUDID - DEVICE: Diff-Quik™ Stain Set (00630414992617)

GUDID

Device Identifier (DI) Information

Brand Name: Diff-Quik™ Stain Set
Version or Model: 10459382
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B4132-1A
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414992617
Issuing Agency: GS1
Commercial Distribution End Date: September 25, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: For differential staining in hematology that gives results similar to a Wright-Giemsa stain

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?
43606	Differentiation solution IVD	A differentiation 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQC	STAINS, HEMATOLOGY

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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ef8eba7-9700-4060-996d-a885129062be
Public Version Date: November 18, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2018