PolyTiter

GUDID 00855574005360

Anti Nuclear Antibody, Calibrator, PolyTiter

POLYMEDCO, INC.

Multiple antinuclear antibody (ANA) screening IVD, calibrator

• Primary Device ID: 00855574005360
• NIH Device Record Key: 66ab1fc7-60c6-4a20-998e-3b3e107dd6c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyTiter
• Version Model Number: ANA-CAL
• 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 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855574005360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012163

FDA Product Code

• DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

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

Devices Manufactured by POLYMEDCO, INC.

• 00816917022925 - Poly stat: 2019-04-26 Flu A & B, Immunochromatographic, 25 Test Kit
• 00816917021546 - Poly stat: 2018-11-08 Mono, Immunochromatographic
• 00855574005360 - PolyTiter: 2018-07-06Anti Nuclear Antibody, Calibrator, PolyTiter
• 00855574005360 - PolyTiter: 2018-07-06 Anti Nuclear Antibody, Calibrator, PolyTiter
• 00855574005377 - Poly stat: 2018-07-06 Qualitative HCG Control
• 00855574005384 - Poly stat: 2018-07-06 HCG, Immunochromatographic Test
• 00855574005391 - Poly stat: 2018-07-06 Qualitative HCG Control, Urine
• 00855574005407 - Poly stat: 2018-07-06 Flu A & B, Immunochromatographic
• 00855574005414 - Poly stat: 2018-07-06 H. Pylori, Immunochromatographic