Detector Cept-D Polyclonal

GUDID 10722355001446

A rapid latex inhibition slide test for the detection of hCG in urine

IMMUNOSTICS COMPANY, INC

Total human chorionic gonadotropin IVD, antibody

• Primary Device ID: 10722355001446
• NIH Device Record Key: 914e920a-a3f9-4dbe-8390-3a89c0ccdab6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Detector Cept-D Polyclonal
• Version Model Number: 43100
• Company DUNS: 119214195
• Company Name: IMMUNOSTICS COMPANY, INC
• Device Count: 100
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10722355001446 [Primary]
GS1	80722355001445 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K842110

FDA Product Code

• JHJ: AGGLUTINATION METHOD, HUMAN CHORIONIC GONADOTROPIN

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

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