Monobind AccuBind PSA Extra Sensitive ELISA Kit - 192 Wells 8725-300B

GUDID 00816870020648

MONOBIND, INC.

Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00816870020648
• NIH Device Record Key: fa5dc889-5e16-44cb-9684-96e04fec9567
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monobind AccuBind PSA Extra Sensitive ELISA Kit - 192 Wells
• Version Model Number: 8725-300
• Catalog Number: 8725-300B
• 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

Device Dimensions

• Width: 7.75 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816870020648 [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

Devices Manufactured by MONOBIND, INC.

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• 00816870020624 - Monobind AccuBind PSA ELISA Kit - 192 Wells: 2020-02-06
• 00816870020631 - Monobind AccuBind PSA Extra Sensitive ELISA Kit - 96 Wells: 2020-02-06
• 00816870020648 - Monobind AccuBind PSA Extra Sensitive ELISA Kit - 192 Wells: 2020-02-06
• 00816870020648 - Monobind AccuBind PSA Extra Sensitive ELISA Kit - 192 Wells: 2020-02-06
• 00816870022277 - Monobind AccuLite Free PSA CLIA Kit - 96 Wells: 2020-02-06
• 00816870022284 - Monobind AccuLite Free PSA CLIA Kit - 192 Wells: 2020-02-06