AccessGUDID - DEVICE: Antigen Retrieval Solution DNS (50X) (00850042030059)

GUDID

Device Identifier (DI) Information

Brand Name: Antigen Retrieval Solution DNS (50X)
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lumatas Biosystems, Inc.

Primary DI Number: 00850042030059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080169635 *Terms of Use

Device Description: Antigen Retrieval (50X) buffer used for antigen unmasking. Antigen unmasking is required for epitope recognition by the primary antibody.

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:	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?
57770	Immunohistochemistry antigen retrieval reagent IVD	A substance or reactant intended to be used for the non-enzymatic retrieval of antigenic epitopes from biological tissues or clinical specimen, using an enzyme immunohistochemistry assay.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJT	Immunohistochemistry Reagents And Kits

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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cfb2fd44-6d06-43a7-a703-137667cb51a0
Public Version Date: November 02, 2023
Public Version Number: 1
DI Record Publish Date: October 25, 2023