GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US

GUDID 00358468000071

GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US

GENZYME CORPORATION

Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD

• Primary Device ID: 00358468000071
• NIH Device Record Key: dce63616-d3f8-410d-bb3d-35633a4e20e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US
• Version Model Number: 762617
• Company DUNS: 050424395
• Company Name: GENZYME CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00358468000071 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-27
• Device Publish Date: 2022-10-19

Devices Manufactured by GENZYME CORPORATION

• 00358468000071 - GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US: 2022-10-27GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US
• 00358468000071 - GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US: 2022-10-27 GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US
• 00358468000057 - NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U: 2020-07-09 NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U
• 00358468000064 - OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US: 2020-07-09 OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US
• 00358468430120 - Seprafilm®: 2019-09-10 Barrier, Absorbable, Adhesion
• 00358468508621 - Seprafilm® Procedure Pack: 2019-09-10 Barrier, Absorbable, Adhesion
• 00358468638014 - Seprafilm® 4-section: 2019-09-10 Barrier, Absorbable, Adhesion
• 00358468664112 - Seprafilm® Single Site: 2019-09-10 Barrier, Absorbable, Adhesion
• 00358468664211 - Seprafilm® Small Incision: 2019-09-10 Barrier, Absorbable, Adhesion