FDA.report

ARK™ Fentanyl Assay

Primary DI
00858724003407
Brand
ARK™ Fentanyl Assay
Company
ARK DIAGNOSTICS INC
Model
5031-0001-00
Catalog number
5031-0001-00
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

Related Records

Contact Domains

Product Codes

CodeName
DJGEnzyme Immunoassay, Opiates

Product Code Classifications

CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00858724003407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00858724003407008587240034078587240034070858724003407

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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