AC&C DeTec hCG Pregnancy Test Device

GUDID 10722355002832

For the qualitative detection of hCG in urine

IMMUNOSTICS COMPANY, INC

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

• Primary Device ID: 10722355002832
• NIH Device Record Key: 0de02629-9673-4ca7-90df-fe2a84e077d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AC&C DeTec hCG Pregnancy Test Device
• Version Model Number: 3025
• Company DUNS: 119214195
• Company Name: IMMUNOSTICS COMPANY, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com
• Phone: +1(800)262-7770
• Email: customerservice@RSNortheast.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10722355002832 [Primary]
GS1	80722355002831 [Unit of Use]

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: 5
• Public Version Date: 2023-07-06
• Device Publish Date: 2016-11-15

Devices Manufactured by IMMUNOSTICS COMPANY, INC

• 10722355001293 - Detector hCG: 2023-07-06 For the qualitative detection of hCG in urine
• 10722355001309 - Detector hCG: 2023-07-06 For the qualitative detection of hCG in urine
• 10722355001316 - Detector hCG: 2023-07-06 For the qualitative detection of hCG in urine
• 10722355001330 - Detector hCG Stick: 2023-07-06 For the qualitative detection of hCG in urine
• 10722355001347 - Detector hCG Stick: 2023-07-06 For the qualitative detection of hCG in urine
• 10722355001354 - Detector hCG Stick: 2023-07-06 For the qualitative detection of hCG in urine
• 10722355001361 - Detector hCG Combi: 2023-07-06 For the qualitative detection of hCG in serum or urine
• 10722355001378 - Detector hCG Combi: 2023-07-06 For the qualitative detection of hCG in serum or urine