INSTANT-VIEW FSH Cassette Test

GUDID 10796918000139

INSTANT-VIEW FSH Cassette Test

ALFA SCIENTIFIC DESIGNS, INC.

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

• Primary Device ID: 10796918000139
• NIH Device Record Key: 70ae6247-0b8d-4c73-975c-79b99792b44a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSTANT-VIEW FSH Cassette Test
• Version Model Number: 02-2562
• Company DUNS: 176391167
• Company Name: ALFA SCIENTIFIC DESIGNS, INC.
• Device Count: 25
• 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	00796918000132 [Unit of Use]
GS1	10796918000139 [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: 3
• Public Version Date: 2019-05-01
• Device Publish Date: 2016-09-21

Devices Manufactured by ALFA SCIENTIFIC DESIGNS, INC.

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• 00796918002426 - INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR300: 2021-08-06 INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR300, MTD, OPI2000, PCP, TCA, THC
• 00796918002419 - INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET,MOR, MTD, OXY, T: 2021-07-20 INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR, MTD, OXY, THC w/ADU
• 00796918002204 - INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300: 2021-04-29 INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET, MOR300, MTD, PCP, TCA, THC
• 00796918002198 - INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR30: 2020-09-22 INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR300, MTD, PCP, TCA, THC
• 20796918001904 - INSTANT-VIEW FOB Test - complete kit, 25 test: 2020-04-06 INSTANT-VIEW FOB Test Fecal Occult Blood – Cassette with mailer 25 tests
• 30796918001901 - INSTANT-VIEW FOB Test - complete kit, 50 test: 2020-04-06 INSTANT-VIEW FOB Test Fecal Occult Blood – Cassette with mailer 50 tests