AccessGUDID - DEVICE: IMMCO DIAGNOSTICS (00845714000645)

GUDID

Device Identifier (DI) Information

Brand Name: IMMCO DIAGNOSTICS
Version or Model: 1152M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1152M
Company Name: IMMCO DIAGNOSTICS, INC.

Primary DI Number: 00845714000645
Issuing Agency: GS1
Commercial Distribution End Date: January 02, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 079935300 *Terms of Use

Device Description: Anti-B2-GP1 IgG Antibody ELISA

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:	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?
54879	Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to beta-2-glycoprotein I in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 96 DETERMINATIONS

Device Record Status

Public Device Record Key: 11993880-bc52-4541-89ff-16405e6360f5
Public Version Date: January 03, 2019
Public Version Number: 3
DI Record Publish Date: September 21, 2016