ARK™ Hydrocodone Assay 5076-0001-01

GUDID 00812101031070

The ARK™ Hydrocodone Assay is an immunoassay intended for the qualitative detection and/ or semi-quantitative estimation of hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL.

ARK DIAGNOSTICS INC

Pethidine IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00812101031070
NIH Device Record Keyddd91c6f-4db8-46b8-92c7-5225e7af6da3
Commercial Distribution StatusIn Commercial Distribution
Brand NameARK™ Hydrocodone Assay
Version Model Number5076-0001-01
Catalog Number5076-0001-01
Company DUNS164880598
Company NameARK DIAGNOSTICS 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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com
Phone5102706270
Emailcustomersupport@ark-tdm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812101031070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-24
Device Publish Date2024-10-16

On-Brand Devices [ARK™ Hydrocodone Assay]

00812101031087The ARK™ Hydrocodone Assay is an immunoassay intended for the qualitative detection and/ or se
00812101031070The ARK™ Hydrocodone Assay is an immunoassay intended for the qualitative detection and/ or se
00812101031063The ARK™ Hydrocodone Assay is an immunoassay intended for the qualitative detection and/ or se

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