Status Strep A Flip BSP-182-05-00

GUDID 10743816000839

Status Strep A card; Flip cassette; 5 Test kit

PRINCETON BIOMEDITECH CORPORATION

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 10743816000839
• NIH Device Record Key: 96fcaaaf-3a1d-4bd6-9147-f7d4614be22e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Status Strep A Flip
• Version Model Number: BSP-182-05-00
• Catalog Number: BSP-182-05-00
• Company DUNS: 362917692
• Company Name: PRINCETON BIOMEDITECH CORPORATION
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10743816000839 [Primary]

FDA Product Code

• GTY: Antigens, All Groups, Streptococcus Spp.

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: 2022-06-10
• Device Publish Date: 2016-09-23

On-Brand Devices [Status Strep A Flip]

• 10743816000846: Status Strep A card; Flip cassette; 12 Test sample kit
• 10743816000839: Status Strep A card; Flip cassette; 5 Test kit
• 10743816000785: Status Strep A card; Flip cassette; 25 Test kit