Monobind AccuBind Free PSA ELISA Kit - 192 Wells 2325-300B

GUDID 00816870020600

MONOBIND, INC.

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

• Primary Device ID: 00816870020600
• NIH Device Record Key: cc5c046b-dbe4-44f7-994f-c9de849240e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monobind AccuBind Free PSA ELISA Kit - 192 Wells
• Version Model Number: 2325-300
• Catalog Number: 2325-300B
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816870020600 [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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• 00816870022284 - Monobind AccuLite Free PSA CLIA Kit - 192 Wells: 2020-02-06