Poly stat

GUDID 00855574005391

Qualitative HCG Control, Urine

POLYMEDCO, INC.

Human chorionic gonadotropin alpha-subunit (alpha-HCG) IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control Human chorionic gonadotropin alpha-subunit IVD, control

• Primary Device ID: 00855574005391
• NIH Device Record Key: 9656f934-8d28-42be-8b35-9f87edac74a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Poly stat
• Version Model Number: HCG-POCU
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855574005391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921206

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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

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