AccessGUDID - DEVICE: AIMSTEP MONO (00695684770259)

GUDID

Device Identifier (DI) Information

Brand Name: AIMSTEP MONO
Version or Model: 77025
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GERMAINE LABORATORIES, INC

Primary DI Number: 00695684770259
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 176458115 *Terms of Use

Device Description: A rapid cassette test for the qualitative detection of Infectious Mononucleosis (IM) heterophile antibodies in serum, plasma, or whole blood.

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:	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?
60620	Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative/quantitative detection of immunoglobulin M (IgM) antibodies to the early antigen (EA) of Epstein-Barr virus (EBV) in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KTN	System, Test, Infectious Mononucleosis

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: e3fa631f-488a-4ffc-ac23-77206b4b5bc1
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 27, 2016