Immunalysis QS-76501

GUDID 00840937103142

Quantisal Saliva Collection Device -100 Per Box, Specimen Bag - 100 Per Box

IMMUNALYSIS CORPORATION

Oral/upper respiratory tract specimen collection kit

• Primary Device ID: 00840937103142
• NIH Device Record Key: 7924e01b-57f4-4d72-8980-38a3a403ec43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immunalysis
• Version Model Number: QS-76501
• Catalog Number: QS-76501
• Company DUNS: 080589004
• Company Name: IMMUNALYSIS CORPORATION
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840937103142 [Unit of Use]
GS1	00840937113912 [Primary]
GS1	00840937113929 [Primary]
GS1	00840937113936 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942435

FDA Product Code

• PJD: Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

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: 2023-04-06
• Device Publish Date: 2023-03-29

Devices Manufactured by IMMUNALYSIS CORPORATION

• 00840937103265 - Immunalysis Corporation: 2023-11-03 Cannabinoid Oral Fluid Calibrator Level 1
• 00840937103272 - Immunalysis Corporation: 2023-11-03 Cannabinoid Oral Fluid Calibrator Level 2
• 00840937103289 - Immunalysis Corporation: 2023-11-03 Cannabinoid Oral Fluid Calibrator Level 3
• 00840937103296 - Immunalysis Corporation: 2023-11-03 Cannabinoid Oral Fluid Calibrator Level 4
• 00840937103302 - Immunalysis Corporation: 2023-11-03 Cannabinoid Oral Fluid Control Set
• 00840937111864 - Immunalysis Corporation: 2023-11-02 SEFRIA 6-Acetylmorphine Oral Fluid Enzyme Immunoassay 100mL Kit
• 00840937111871 - Immunalysis Corporation: 2023-11-02 SEFRIA 6-Acetylmorphine Oral Fluid Enzyme Immunoassay 500mL Kit
• 00840937112007 - Immunalysis Corporation: 2023-11-02 SEFRIA Amphetamine Oral Fluid Enzyme Immunoassay 100mL Kit