Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit C/G-DFA

GUDID 00854624006005

IVD RESEARCH, INC.

Cryptosporidium species antigen IVD, kit, direct fluorescent test (DFT)
Primary Device ID00854624006005
NIH Device Record Keye96e0577-d6d8-491e-93f2-30018443a84a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCrypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit
Version Model NumberC/G-DFA
Catalog NumberC/G-DFA
Company DUNS965482789
Company NameIVD RESEARCH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854624006005 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-03

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