ARK™ Ketamine Negative Calibrator 5056-0002-01

GUDID 00812101030035

ARK™ Ketamine Negative Calibrator is intended for use in calibration of the ARK™ Ketamine Assay.

ARK DIAGNOSTICS INC

Ketamine/ketamine metabolite IVD, calibrator

• Primary Device ID: 00812101030035
• NIH Device Record Key: 656a73be-01cf-4d02-ab5d-1d1dd0e42263
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Ketamine Negative Calibrator
• Version Model Number: 5056-0002-01
• Catalog Number: 5056-0002-01
• Company DUNS: 164880598
• Company Name: ARK DIAGNOSTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5102706270
• Email: customersupport@ark-tdm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812101030035 [Primary]

FDA Product Code

• DLJ: Calibrators, Drug Specific

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-31
• Device Publish Date: 2019-07-23

Devices Manufactured by ARK DIAGNOSTICS INC

• 00812101031599 - ARK™ Ketamine II Assay: 2026-01-05 The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketami
• 00812101031605 - ARK™ Ketamine II Assay: 2026-01-05 The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketami
• 00812101031612 - ARK™ Ketamine II Assay: 2026-01-05 The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketami
• 00812101031629 - ARK™ Ketamine II Calibrator: 2026-01-05 The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.
• 00812101031636 - ARK™ Ketamine II Calibrator (Negative): 2026-01-05 The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.
• 00812101031643 - ARK™ Ketamine II Calibrator (50 ng/mL Cutoff): 2026-01-05 The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.
• 00812101031650 - ARK™ Ketamine II Calibrator (100 ng/mL Cutoff): 2026-01-05 The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.
• 00812101031667 - ARK™ Ketamine II Control (25/75): 2026-01-05 The ARK Ketamine II Control is intended for use in quality control of the ARK Ketamine II Assay.