PlaySafe™ SCK10690

GUDID 05055273220018

The PlaySafe kit is intended for use in the collection of a urine sample for laboratory analysis of nine sexually transmitted infections: (Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex virus I, Herpes simplex virus II, Trichomonas vaginalis, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum & Haemophilus ducreyi (chancroid). This device is intended for sample collection purpose only. Samples may be collected at home through adherence to the Instructions for Use (IFU) document or may be collected under the guidance of a medical professional.

RANDOX LABORATORIES LIMITED

Urine specimen collection kit IVD

• Primary Device ID: 05055273220018
• NIH Device Record Key: 2e2dd67e-85e9-4fff-b1a3-b991f725e377
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlaySafe™
• Version Model Number: SCK10690
• Catalog Number: SCK10690
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true

Customer Support Contacts

• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com
• Phone: 304-728-2890
• Email: info@randoxhealthla.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273220018 [Primary]

FDA Product Code

• OIE: Urine Collection Kit (Excludes Hiv Testing)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-09
• Device Publish Date: 2024-10-01

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