FDA.report

ARK™ Fentanyl Control (WPT)

Primary DI
00858724003698
Brand
ARK™ Fentanyl Control (WPT)
Company
ARK DIAGNOSTICS INC
Model
5052-0003-00
Catalog number
5052-0003-00
Device description
ARK™ Fentanyl Control is intended for use in quality control of the ARK™ Fentanyl Assay.
Published
2018-04-26
Public version status
New
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
LASDrug Specific Control Materials

Product Code Classifications

CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00858724003698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00858724003698008587240036988587240036980858724003698

GMDN Terms

TermDefinition
Opiate/opiate metabolite IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen.

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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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
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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
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