AccessGUDID - DEVICE: IMMUNO CONCEPTS Test Systems (M7491012201)

GUDID

Device Identifier (DI) Information

Brand Name: IMMUNO CONCEPTS Test Systems
Version or Model: 1012 (20)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1012 (20)
Company Name: IMMUNO CONCEPTS INC

Primary DI Number: M7491012201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038271904 *Terms of Use

Device Description: Universal PBS Buffer Powder - 20 x 1 Pkg.

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?
42693	pH-adjusted buffer solution IVD	A pH-adjusted buffer solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 879b6ae4-9455-454b-93d2-8639f5db5b4d
Public Version Date: November 13, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016