FDA.report

ARK™ Pregabalin Urine Calibrator

Primary DI
00858724003292
Brand
ARK™ Pregabalin Urine Calibrator
Company
ARK DIAGNOSTICS INC
Model
5035-0002-00
Catalog number
5035-0002-00
Device description
ARK™ Pregabalin Urine Calibrator is intended for use in calibration of the ARK™ Pregabalin Urine Assay.
Published
2016-09-24
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
00858724003292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00858724003292008587240032928587240032920858724003292

GMDN Terms

TermDefinition
Multiple anticonvulsant therapeutic drug monitoring IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple anticonvulsant drugs, also known as antiepileptic drugs which may include carbamazepine, lamotrigine, phenytoin, and primidone, 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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