To Life HCG Pregnancy Test Strip

GUDID 10722355002825

For the qualitative detection of hCG in urine

IMMUNOSTICS COMPANY, INC

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• Primary Device ID: 10722355002825
• NIH Device Record Key: 947de9b8-34b0-414d-965d-3b2bb59e94f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: To Life HCG Pregnancy Test Strip
• Version Model Number: 2010
• 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	10722355002825 [Primary]
GS1	80722355002824 [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

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• 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