MP Diagnostics HTLV Blot 2.4 07110888036

GUDID 00888758100016

The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.

MP BIOMEDICALS ASIA PACIFIC PTE. LTD.

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot

• Primary Device ID: 00888758100016
• NIH Device Record Key: cdbd4c55-b1f5-46d5-8f5e-6f08a946da35
• Commercial Distribution Discontinuation: 2035-10-02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MP Diagnostics HTLV Blot 2.4
• Version Model Number: 36 test
• Catalog Number: 07110888036
• Company DUNS: 595128042
• Company Name: MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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: 440.337.1200
• Email: mpHTLV@mpbio.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888758100016 [Primary]

FDA Product Code

• MTP: Antibody To Htlv-1, Elisa

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: 2018-03-29
• Device Publish Date: 2015-03-11

On-Brand Devices [MP Diagnostics HTLV Blot 2.4]

• 00888758100016: The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the
• 00888758100009: The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the