Be Sure

GUDID 10748349000707

Menopause Test - 1 Test

SYNTRON BIORESEARCH, INC.

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

• Primary Device ID: 10748349000707
• NIH Device Record Key: 49647380-64b3-45f4-96cb-4c711ff0608c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Be Sure
• Version Model Number: Midstream
• Company DUNS: 174517060
• Company Name: SYNTRON BIORESEARCH, INC.
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00748349000700 [Primary]
GS1	10748349000707 [Package]; Contains: 00748349000700; Package: Shipping Case [48 Units]; In Commercial Distribution

FDA Product Code

• NGA: Test, Follicle Stimulating Hormone (Fsh), Over The Counter

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: 2020-07-27
• Device Publish Date: 2020-07-17

Devices Manufactured by SYNTRON BIORESEARCH, INC.

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• 10748349000707 - Be Sure: 2020-07-27Menopause Test - 1 Test
• 10748349000707 - Be Sure: 2020-07-27 Menopause Test - 1 Test
• 20748349000018 - QuikScreen 11+3 Drug Cup Test: 2018-07-06 QuikScreen 11+3: AMP 1000, BAR 300, BUP 10, BZD 300, MAD 300, MDMA 500, MET 1000, OPI 2000, OXY 100, PCP 25, THC 50 + adulterant
• 30748349000022 - ForSure iFOB Test Set: 2018-07-06 ForSure iFOB test set Contains: 1 test device 1 test reagent buffer 1 sample collection set (may or may not be included)
• 20748349000049 - QuikSreen 11 Drug Cup Test: 2018-07-06 QuikSreen 11 Drug Cup Test: AMP1000, BAR300, BUP10, BZD300, COC300, MAD300, MDMA500, MET1000, OPI300, OXY100, THC50
• 20748349000056 - QuikScreen 5 Drug Cup Test: 2018-07-06 QuikScreen 5: AMP 1000, COC 300, OPI 2000, PCP 25, THC 50
• 10748349000066 - QuikStrip MultiDrug 4 Dip Card Test: 2018-07-06 QuikStrip MultiDrug 4 Dip Card: MAD300, OXY 300, OPI300, BZD200