Toxigenic C. difficile Direct Test 300786

GUDID G491CDF21

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Primary Device ID	G491CDF21
NIH Device Record Key	ed2f2e9b-54d2-405d-9494-8e09186b7606
Commercial Distribution Status	In Commercial Distribution
Brand Name	Toxigenic C. difficile Direct Test
Version Model Number	01
Catalog Number	300786
Company DUNS	117416922
Company Name	Vela Operations USA Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	G491CDF20 [Primary]
HIBCC	G491CDF21 [Package] Contains: G491CDF20 Package: EA [10 Units] In Commercial Distribution

OZN	C. Difficile Toxin Gene Amplification Assay

Steralize Prior To Use	false
Device Is Sterile	false

G491CDF21 - Toxigenic C. difficile Direct Test	2024-01-26
G491CDF21 - Toxigenic C. difficile Direct Test	2024-01-26
G491CDF2SPD0 - Toxigenic C. difficile Direct Test - Sample Prep	2024-01-26