Accutest Value+ Strep A Rapid Test Strip

GUDID 10763924513199

Strep A Rapid Test Strip (Throat Swab)

JANT PHARMACAL CORPORATION

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• Primary Device ID: 10763924513199
• NIH Device Record Key: e65f4bd6-eb37-42c4-9f6e-8c5c28373c4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accutest Value+ Strep A Rapid Test Strip
• Version Model Number: ID513
• Company DUNS: 797393659
• Company Name: JANT PHARMACAL CORPORATION
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763924513192 [Unit of Use]
GS1	10763924513199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983386

FDA Product Code

• GTY: Antigens, All Groups, Streptococcus Spp.

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-24

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