AccessGUDID - DEVICE: Secondary reagents blot (IgG) (04049016114642)

GUDID

Device Identifier (DI) Information

Brand Name: Secondary reagents blot (IgG)
Version or Model: ZD 1129-0101 G
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EUROIMMUN Medizinische Labordiagnostika AG

Primary DI Number: 04049016114642
Issuing Agency: GS1
Commercial Distribution End Date: December 08, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 322209263 *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):	No
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?
65835	Enzyme immunoassay (EIA) generic reagent kit IVD	A collection of general reagents and other associated materials intended to be used to perform an enzyme immunoassay on clinical specimens; it is not dedicated to the detection of any one type of analyte. It typically consists of an enzyme conjugate, blocking buffer, wash buffer and a substrate solution.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 05d96993-1701-4789-8809-341d56155751
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022