Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived)

GUDID 10763924851109

Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived)

JANT PHARMACAL CORPORATION

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 10763924851109
• NIH Device Record Key: 5f783338-bbb2-49df-94c7-eae1118e70af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived)
• Version Model Number: PF851
• 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: 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	00763924851102 [Unit of Use]
GS1	10763924851109 [Primary]

FDA Product Code

• JHI: Visual, Pregnancy Hcg, Prescription Use

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: 2023-07-06
• Device Publish Date: 2016-09-20

Devices Manufactured by JANT PHARMACAL CORPORATION

• 10763924851109 - Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived): 2023-07-06Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived)
• 10763924851109 - Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived): 2023-07-06 Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived)
• 10763924853202 - Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived): 2023-07-06 Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived)
• 10763924864208 - Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine): 2023-07-06 Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine)
• 10763924095213 - Accutest Breath Alcohol Detector: 2022-11-28 Breath Alcohol Detector, .02 % BAC.
• 10763924097224 - Accustrip Saliva Alcohol Test: 2022-11-28 Saliva Alcohol Test Strip
• 10763924210142 - Accutest: 2022-11-28 2 Parameter Urine Reagent Strip (Glucose, Protein)
• 10763924410146 - Accutest: 2022-11-28 4-Parameter Urine Reagent Strip (Glucose, Protein, Nitrite, Leukocytes
• 10763924601568 - ACCUTEST Uriscreen Rapid Screen for UTI. Test: 2022-11-28 Rapid Screen for UTI, testing for Bacteriuria and presence of Somatic Cells in Urine.