Oratect Oral Fluid Collection Tube CM-190

GUDID 00816565020847

Oral Fluid Specimen Collection Tube

AMEDITECH INC.

Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD

• Primary Device ID: 00816565020847
• NIH Device Record Key: 201ec915-6e8e-40d9-abaf-d391a276c33a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oratect Oral Fluid Collection Tube
• Version Model Number: CM-190
• Catalog Number: CM-190
• Company DUNS: 010551716
• Company Name: AMEDITECH 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: 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: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store collected specimen between 2 to 8 Degrees Celsius.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816565020847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103227

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-31

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