Quality Choice One Step Pregnancy Test

GUDID 10635515900483

FPPL Quality Choice SPS +/-

CHAIN DRUG MARKETING ASSOCIATION, INC.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10635515900483
• NIH Device Record Key: 0d34cdbc-9cbe-485a-ba4e-63d6bce90054
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quality Choice One Step Pregnancy Test
• Version Model Number: FPPL
• Company DUNS: 011920774
• Company Name: CHAIN DRUG MARKETING ASSOCIATION, INC.
• Device Count: 1
• 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: true

Customer Support Contacts

• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00635515900486 [Primary]
GS1	10635515800127 [Package]; Contains: 00635515900486; Package: Shipping Case [6 Units]; Discontinued: 2009-06-24; Not in Commercial Distribution
GS1	10635515900483 [Package]; Contains: 00635515900486; Package: Shipping Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042280

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

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: 2018-07-06
• Device Publish Date: 2016-07-21

On-Brand Devices [Quality Choice One Step Pregnancy Test]

• 00635515900493: FPPL Quality Choice DPS +/-
• 10635515900483: FPPL Quality Choice SPS +/-