DRI™ Fentanyl II Control 10028875

GUDID 00812101030790

Opiate/opiate metabolite IVD, control

Primary Device ID	00812101030790
NIH Device Record Key	93bf0e69-4ba6-46c7-b9ab-60cc6edd4df0
Commercial Distribution Status	In Commercial Distribution
Brand Name	DRI™ Fentanyl II Control
Version Model Number	10028875
Catalog Number	10028875
Company DUNS	164880598
Company Name	ARK DIAGNOSTICS 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

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00812101030790 [Primary]

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false

00812101031599 - ARK™ Ketamine II Assay	2026-01-05 The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketami
00812101031605 - ARK™ Ketamine II Assay	2026-01-05 The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketami
00812101031612 - ARK™ Ketamine II Assay	2026-01-05 The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketami
00812101031629 - ARK™ Ketamine II Calibrator	2026-01-05 The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.
00812101031636 - ARK™ Ketamine II Calibrator (Negative)	2026-01-05 The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.
00812101031643 - ARK™ Ketamine II Calibrator (50 ng/mL Cutoff)	2026-01-05 The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.
00812101031650 - ARK™ Ketamine II Calibrator (100 ng/mL Cutoff)	2026-01-05 The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.
00812101031667 - ARK™ Ketamine II Control (25/75)	2026-01-05 The ARK Ketamine II Control is intended for use in quality control of the ARK Ketamine II Assay.