AccessGUDID - DEVICE: Antisera to Human Immunoglobulins Pentavalent (G, A, M, D, E) (M52592510)

GUDID

Device Identifier (DI) Information

Brand Name: Antisera to Human Immunoglobulins Pentavalent (G, A, M, D, E)
Version or Model: 9251
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HELENA LABORATORIES CORPORATION

Primary DI Number: M52592510
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079396131 *Terms of Use

Device Description: No description.

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?
57308	Polyvalent human immunoglobulin antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of all classes of human immunoglobulin (i.e, IgA, IgE, IgD, IgG, IgM) and/or specific immunoglobulin chains in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CFF	IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M)

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 669585b8-2332-4566-b154-930ba8b7f165
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 07, 2016