Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit

Basic Information

• Brand Name: Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit
• Primary DI: 00854624006005
• Version / Model: C/G-DFA
• Catalog Number: C/G-DFA
• Company Name: IVD RESEARCH, INC.
• Labeler DUNS: 965482789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-03
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: e96e0577-d6d8-491e-93f2-30018443a84a

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Obsolete
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).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854624006005	GS1