323-16-12

GUDID 30858512007106

Liquid Urine Control - Level 1/Level 2, 10 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C.

ALTA DIAGNOSTICS INC

Multiple urine analyte IVD, control

• Primary Device ID: 30858512007106
• NIH Device Record Key: 0b33c3bd-ee7c-4f5b-b718-a13c238751ec
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 323-16-12
• Catalog Number: 323-16-12
• Company DUNS: 859323297
• Company Name: ALTA 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 775-283-5780
• Email: technical@altadiagnostics.com

Device Dimensions

• Total Volume: 10 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30858512007106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890577

FDA Product Code

• JJW: Urinalysis Controls (Assayed And Unassayed)

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: 2019-04-08
• Device Publish Date: 2019-03-29

Devices Manufactured by ALTA DIAGNOSTICS INC

• 30858512007007 - NA: 2019-04-08 Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability wh
• 30858512007014 - NA: 2019-04-08 Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability wh
• 10858512007034 - NA: 2019-04-08 Liquid Urine Control Dipstick - Negative, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability wh
• 30858512007045 - NA: 2019-04-08 Liquid Urine Control Dipstick - Positive, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability wh
• 10858512007065 - NA: 2019-04-08 Liquid Urine Control for Microscopic and High Specific Gravity - Positive, 250 ml. 18 month open vial stability when stored at 2
• 10858512007072 - NA: 2019-04-08 Liquid Urine Control for Microscopic and High Specific Gravity - Negative, 250 ml. 18 month open vial stability when stored at 2
• 30858512007083 - NA: 2019-04-08 Liquid Urine Control - Level 1, 10 ml. 18 month open vial stability when stored at 2-8° C.
• 30858512007090 - NA: 2019-04-08 Liquid Urine Control - Level 2, 10 ml. 18 month open vial stability when stored at 2-8° C.