AccessGUDID - DEVICE: Detector Color IM (10722355001200)

GUDID

Device Identifier (DI) Information

Brand Name: Detector Color IM
Version or Model: IMC-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMMUNOSTICS COMPANY, INC

Primary DI Number: 10722355001200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 119214195 *Terms of Use

Device Description: A simple color enhanced slide test for the detection of infectious mononucleosis

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):	Yes
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?
49688	Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of heterophile antibodies produced in response to Epstein-Barr virus (EBV) in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTN	SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K861016	000

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Do not freeze

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: da5f81fa-4ded-446a-b171-88ac5a7c558a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016