Fluorescent Treponemal Antibody- Absorption Double Stain (FTA-ABS DS) FA7001DS

GUDID 00845533002080

The Fluorescent Treponemal Antibody-Absorption Double Stain (FTA-ABS DS) Test System is designed to confirm positive non-treponemal regain tests for syphilis and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

ZEUS SCIENTIFIC, INC.

Treponema pallidum total antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 00845533002080
• NIH Device Record Key: 4584cfb7-ee8f-425f-8fe2-2543fba5c567
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluorescent Treponemal Antibody- Absorption Double Stain (FTA-ABS DS)
• Version Model Number: FA7001DS
• Catalog Number: FA7001DS
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, 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: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533002080 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-19
• Device Publish Date: 2025-11-11

Devices Manufactured by ZEUS SCIENTIFIC, INC.

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• 00845533002080 - Fluorescent Treponemal Antibody- Absorption Double Stain (FTA-ABS DS): 2025-11-19The Fluorescent Treponemal Antibody-Absorption Double Stain (FTA-ABS DS) Test System is designed to confirm positive non-treponemal regain tests for syphilis and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
• 00845533002080 - Fluorescent Treponemal Antibody- Absorption Double Stain (FTA-ABS DS): 2025-11-19 The Fluorescent Treponemal Antibody-Absorption Double Stain (FTA-ABS DS) Test System is designed to confirm positive non-trepone
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