AccessGUDID - DEVICE: AIM-V Medium (05051716000162)

GUDID

Device Identifier (DI) Information

Brand Name: AIM-V Medium
Version or Model: AV.200/50
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AV.200/50
Company Name: Oxford Immunotec, Inc.

Primary DI Number: 05051716000162
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009744265 *Terms of Use

Device Description: AIM-V® serum free cell culture medium is intended for use in the preparation of peripheral blood mononuclear cells (PBMCs) from whole blood and for use as a culture medium for in vitro testing using the ELISPOT method. PBMCs, separated from whole blood samples, are washed with AIM-V medium and the cell pellet is re-suspended in the medium. The cells are counted using a haemocytometer or automated cell counter before being diluted to the required concentration in AIM-V.

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?
58567	Cell culture medium IVD	A liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZI	Culture Media, Enriched

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: Yes
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: 3850a576-5262-407e-ad51-1a2bcb21ac11
Public Version Date: February 15, 2023
Public Version Number: 1
DI Record Publish Date: February 07, 2023