FDA.report

ARK™ Fentanyl Cutoff Calibrator

Primary DI
00858724003452
Brand
ARK™ Fentanyl Cutoff Calibrator
Company
ARK DIAGNOSTICS INC
Model
5031-0002-02
Catalog number
5031-0002-02
Device description
ARK™ Fentanyl Cutoff Calibrator is intended for use in the calibration of the ARK™ Fentanyl Assay.
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
DLJCalibrators, Drug Specific

Product Code Classifications

CodeDeviceSpecialtyClass
DLJCalibrators, Drug SpecificClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00858724003452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00858724003452008587240034528587240034520858724003452

GMDN Terms

TermDefinition
Opiate/opiate metabolite IVD, calibratorA material which is used to establish known points of reference for 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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