Poly stat

GUDID 00816917021546

Mono, Immunochromatographic

POLYMEDCO, INC.

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00816917021546
• NIH Device Record Key: 49df58ec-4fed-407b-b211-fbb840e02412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Poly stat
• Version Model Number: MN20
• 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	00816917021546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961024

FDA Product Code

• KTN: System, Test, Infectious Mononucleosis

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: 2018-11-08
• Device Publish Date: 2016-09-23

On-Brand Devices [Poly stat]

• 00816917021546: Mono, Immunochromatographic
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• 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