FDA.reportPublic FDA data

ARK™ Fentanyl Negative Calibrator (WPT)

Primary DI
00858724003681
Brand
ARK™ Fentanyl Negative Calibrator (WPT)
Company
ARK DIAGNOSTICS INC
Model
5052-0002-01
Catalog number
5052-0002-01
Device description
ARK™ Fentanyl Negative Calibrator is intended for use in the calibration 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DLJCalibrators, Drug Specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLJCalibrators, Drug SpecificClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858724003681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858724003681008587240036818587240036810858724003681

GMDN Terms#

Term, Definition table
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#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812101031629ARK™ Ketamine II CalibratorARK DIAGNOSTICS INCDLJ2025-12-27
00812101031636ARK™ Ketamine II Calibrator (Negative)ARK DIAGNOSTICS INCDLJ2025-12-27
00812101031643ARK™ Ketamine II Calibrator (50 ng/mL Cutoff)ARK DIAGNOSTICS INCDLJ2025-12-27
00812101031650ARK™ Ketamine II Calibrator (100 ng/mL Cutoff)ARK DIAGNOSTICS INCDLJ2025-12-27
00840937114568ImmunalysisIMMUNALYSIS CORPDLJ2024-04-08
00840937114605ImmunalysisIMMUNALYSIS CORPDLJ2024-04-08
07613336224830MTX CalibratorRoche Diagnostics GmbHDLJ2024-03-25
00840937103265Immunalysis CorporationIMMUNALYSIS CORPORATIONDLJ2023-10-26
00840937103272Immunalysis CorporationIMMUNALYSIS CORPORATIONDLJ2023-10-26
00840937103289Immunalysis CorporationIMMUNALYSIS CORPORATIONDLJ2023-10-26
00840937103296Immunalysis CorporationIMMUNALYSIS CORPORATIONDLJ2023-10-26
00894354002366Beckman CoulterSALADAX BIOMEDICAL, INC.DLJ2022-06-15
B07604120LZI Tramadol Low CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07604130LZI Tramadol Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07604140LZI Tramadol Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07604150LZI Tramadol High CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07605220LZI Cotinine II Low CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
B07605230LZI Cotinine II Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
B07605240LZI Cotinine II Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
B07605250LZI Cotinine II High CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
00894354002212MyCare PsychiatrySALADAX BIOMEDICAL, INC.DLJ2022-01-27
00850624008278Fentanyl Qualitative Calibrator SetLIN-ZHI INTERNATIONAL, INC.DLJ2021-10-18
00812101030509ARK™ HS Benzodiazepine II CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030516ARK™ HS Benzodiazepine II Negative CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030523ARK™ HS Benzodiazepine II 100ng/mL Cutoff CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030530ARK™ HS Benzodiazepine II 200ng/mL Cutoff CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
B07606250LZI Oxycodone 300 High CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2021-08-19
B07606120LZI Oxycodone 100 Low CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2021-08-18
B07606130LZI Oxycodone 100 Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2021-08-18
B07606140LZI Oxycodone 100 Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2021-08-18