Poly stat

GUDID 00855574005438

Strep A, Immunochromatographic, Flip

POLYMEDCO, INC.

Beta-haemolytic Group A Streptococcus antigen IVD, kit, immunochromatographic test (ICT), rapid Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 00855574005438
• NIH Device Record Key: 3410ad6a-cc96-459d-92dd-867c6c812f04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Poly stat
• Version Model Number: STF25
• 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	00855574005438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040708

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: 2018-07-06
• 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