Poly stat

GUDID 00816917022925

Flu A & B, Immunochromatographic, 25 Test Kit

POLYMEDCO, INC.

Influenza A/B virus neuraminidase activity IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00816917022925
• NIH Device Record Key: fc125596-114d-42ed-b236-2a1dd7281c81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Poly stat
• Version Model Number: FLU25
• Company DUNS: 024798555
• Company Name: POLYMEDCO, 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: 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: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816917022925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132465

FDA Product Code

• GNX: Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

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: 2019-04-26
• Device Publish Date: 2019-04-18

On-Brand Devices [Poly stat]

• 00816917021546: Mono, Immunochromatographic
• 00855574005438: Strep A, Immunochromatographic, Flip
• 00855574005421: Strep A, Immunochromatographic
• 00855574005414: H. Pylori, Immunochromatographic
• 00855574005407: Flu A & B, Immunochromatographic
• 00855574005391: Qualitative HCG Control, Urine
• 00855574005384: HCG, Immunochromatographic Test
• 00855574005377: Qualitative HCG Control
• 00816917022925: Flu A & B, Immunochromatographic, 25 Test Kit