AccessGUDID - DEVICE: RESt (10888234001003)

GUDID

Device Identifier (DI) Information

Brand Name: RESt
Version or Model: 0057316
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0057316
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234001003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: RESt (Rabbit Erythrocyte Stroma) is used to adsorb cold reactive autoagglutins such as anti-I, anti-H or anti-IH, for human serum or plasma to facilitate the resolution of serological complexities. RESt contains a saline suspension of rabbit erythrocyte stroma. This package configuration is eight (8) tube tests.

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):	Yes
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?
43805	Immunoglobulin removal reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs for the removal, adsorption, absorption, or inactivation of non-specific immunoglobulins and/or rheumatoid factor antibodies present in a clinical specimen, to prevent interference when testing for other specific classes of immunoglobulin.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSQ	Reagent, Rickettsia Serological

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 1 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6fa89ae-a3fd-4bc1-9ab3-ed4ffac15755
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 19, 2016