Monobind AccuLite Free PSA CLIA Kit - 96 Wells 2375-300A

GUDID 00816870022277

MONOBIND, INC.

Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00816870022277
• NIH Device Record Key: 98901413-ef1f-4a35-a634-b568dd999bfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monobind AccuLite Free PSA CLIA Kit - 96 Wells
• Version Model Number: 2375-300
• Catalog Number: 2375-300A
• Company DUNS: 083155515
• Company Name: MONOBIND, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com
• Phone: +1(949)951-2665
• Email: info@monobind.com

Device Dimensions

• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch
• Width: 7.75 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816870022277 [Primary]

FDA Product Code

• LTJ: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-02-11

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