AccessGUDID - DEVICE: Retic-Chex II (20844509000383)

GUDID

Device Identifier (DI) Information

Brand Name: Retic-Chex II
Version or Model: 285204
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 285204
Company Name: STRECK, INC.

Primary DI Number: 20844509000383
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 072915986 *Terms of Use

Device Description: A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 4 vials of level 2.

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?
30537	Reticulocyte count IVD, control	A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JPK	Mixture, Hematology Quality Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1.0 Milliliter

Device Record Status

Public Device Record Key: 77cdf3bb-1ed2-4c33-98f6-c3c11b798a93
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 19, 2016