AccessGUDID - DEVICE: Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit (00854624006005)

GUDID

Device Identifier (DI) Information

Brand Name: Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit
Version or Model: C/G-DFA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C/G-DFA
Company Name: IVD RESEARCH, INC.

Primary DI Number: 00854624006005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 965482789 *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:	No
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?
52161	Cryptosporidium species antigen IVD, kit, direct fluorescent test (DFT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from species of the parasitic protozoan Cryptosporidium in a clinical specimen, using a direct fluorescent test (DFT).	Obsolete	false
52248	Giardia lamblia antigen IVD, kit, direct fluorescent test (DFT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the parasitic protozoan Giardia lamblia in a clinical specimen, using a direct fluorescent test (DFT).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: e96e0577-d6d8-491e-93f2-30018443a84a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 03, 2016