FDA.reportPublic FDA data

ARK™ Fentanyl Assay

Primary DI
00858724003438
Brand
ARK™ Fentanyl Assay
Company
ARK DIAGNOSTICS INC
Model
5031-0001-01
Catalog number
5031-0001-01
Device description
The ARK™ Fentanyl Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative and determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting fentanyl in urine on automated clinical chemistry analyzers.
Published
2017-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DJGEnzyme Immunoassay, Opiates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858724003438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858724003438008587240034388587240034380858724003438

GMDN Terms#

Term, Definition table
TermDefinition
Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5102706270customersupport@ark-tdm.com

Regulatory Flags#

DUNS number
164880598
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812101030240ARK™ UR-144/JWH-018 Assay5054-0001-005054-0001-002019-07-23
00812101030257ARK™ UR-144/JWH-018 Assay5054-0001-015054-0001-012019-07-23
00812101030264ARK™ UR-144/JWH-018 Negative Calibrator5054-0002-015054-0002-012019-07-23
00812101030271ARK™ UR-144/JWH-018 Cutoff Calibrator5054-0002-025054-0002-022019-07-23
00812101030288ARK™ UR-144/JWH-018 Control5054-0003-005054-0003-002019-07-23
00812101030349ARK™ AB-PINACA Assay5055-0001-005055-0001-002019-07-23
00812101030356ARK™ AB-PINACA Assay5055-0001-015055-0001-012019-07-23
00812101030363ARK™ AB-PINACA Negative Calibrator5055-0002-015055-0002-012019-07-23
00812101030370ARK™ AB-PINACA Cutoff Calibrator5055-0002-025055-0002-022019-07-23
00812101030387ARK™ AB-PINACA Control5055-0003-005055-0003-002019-07-23
00812101031599ARK™ Ketamine II Assay5083-0001-005083-0001-002025-12-27
00812101031605ARK™ Ketamine II Assay5083-0001-015083-0001-002025-12-27
00812101031612ARK™ Ketamine II Assay5083-0001-025083-0001-022025-12-27
00812101031629ARK™ Ketamine II Calibrator5083-0002-005083-0002-002025-12-27
00812101031636ARK™ Ketamine II Calibrator (Negative)5083-0002-015083-0002-012025-12-27
00812101031643ARK™ Ketamine II Calibrator (50 ng/mL Cutoff)5083-0002-025083-0002-022025-12-27
00812101031650ARK™ Ketamine II Calibrator (100 ng/mL Cutoff)5083-0002-035083-0002-032025-12-27
00812101031667ARK™ Ketamine II Control (25/75)5083-0003-005083-0003-002025-12-27
00812101031674ARK™ Ketamine II Control (75/125)5083-0003-015083-0003-012025-12-27
00812101031995ARK™ Ketamine II Assay5083-0001-035083-0001-032025-12-27

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Primary DI, Brand, Company table
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00812101031049DRI Tramadol Calibrator KitARK DIAGNOSTICS INCDJG2024-11-14
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