INSTANT-VIEW FSH Midstream Cassette Test, 2t

GUDID 10796918002003

INSTANT-VIEW FSH Midstream Cassette Test, 2t

ALFA SCIENTIFIC DESIGNS, INC.

Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10796918002003
• NIH Device Record Key: a1a09bd5-06dd-41e6-b3f9-6738d6a201ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSTANT-VIEW FSH Midstream Cassette Test, 2t
• Version Model Number: 02-2560-2
• Company DUNS: 176391167
• Company Name: ALFA SCIENTIFIC DESIGNS, INC.
• Device Count: 2
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00796918002006 [Unit of Use]
GS1	10796918002003 [Primary]

FDA Product Code

• CGJ: Radioimmunoassay, Follicle-Stimulating Hormone

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: 2019-05-02
• Device Publish Date: 2018-10-29

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