AccessGUDID - DEVICE: Adsorb Out (00812117015255)

GUDID

Device Identifier (DI) Information

Brand Name: Adsorb Out
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ADSORB
Company Name: ONE LAMBDA, INC.

Primary DI Number: 00812117015255
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118289289 *Terms of Use

Device Description: To reduce high background that is caused by nonspecific binding of materials in human sera to the latex beads used in flow antibody detection assays.

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):	Yes
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?
62511	DNA blocking reagent IVD	A substance or reactant intended to be used to decrease the background noise caused by non-specific binding or hybridization, during the detection of nucleic acids in assays performed on a clinical specimen. Examples of blocking reagents may include (but are not limited to) Cot-1 DNA, tRNA and bovine serum albumin (BSA).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

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: less than -65 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1aed2d49-6c87-4a03-897d-204a4bd2c5db
Public Version Date: July 16, 2018
Public Version Number: 1
DI Record Publish Date: June 15, 2018