AccessGUDID - DEVICE: Streck Cell Preservative (10844509000843)

GUDID

Device Identifier (DI) Information

Brand Name: Streck Cell Preservative
Version or Model: 213350
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 213350
Company Name: STRECK, INC.

Primary DI Number: 10844509000843
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 072915986 *Terms of Use

Device Description: An easy-to-use liquid preservative that maintains cellular antigen expression, including cluster of differentiation (CD) markers and cell morphology of biological samples for analysis by flow cytometry. Contains six (6) 1.0 ml vials.

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):	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?
41413	Lymphocyte stabilization reagent IVD	A substance or reactant intended to be used for the stabilization, preservation and/or storage of lymphocytes following separation from a whole blood clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LEA	Preservative, Cytological

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 18 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1.0 Milliliter

Device Record Status

Public Device Record Key: dcf343f7-b478-4ac9-8251-1ad6d97db486
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 19, 2016