AccessGUDID - DEVICE: Accu-Sed® Test Kit, 4x8.5mL 2 Normal & 2 Abnormal (03661540304071)

GUDID

Device Identifier (DI) Information

Brand Name: Accu-Sed® Test Kit, 4x8.5mL 2 Normal & 2 Abnormal
Version or Model: DS-71006
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ELITECHGROUP INC.

Primary DI Number: 03661540304071
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052423787 *Terms of Use

Device Description: Accu-Sed Plus ESR Controls are whole blood reference control materials designed to monitor patient erythrocyte sedimentation rate (ESR) procedures. Accu-Sed Plus Normal / Abnormal ESR Controls help to monitor technique as well as environmental, physical and mechanical factors such as room temperature, tube position, and vibration.

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:	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?
55972	Erythrocyte sedimentation rate (ESR) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

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
No Device Sizes

Device Record Status

Public Device Record Key: 8ddf838e-f159-405b-bfae-245d876f11bd
Public Version Date: March 01, 2021
Public Version Number: 1
DI Record Publish Date: February 19, 2021