Actim PROM

GUDID 06430030990615

Actim PROM test pouch. Each pouch includes: - One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solution contains bovine serum albumin (BSA), protease inhibitors and preservatives. - One dipstick in a sealed aluminum foil pouch with desiccant. - One sterile polyester swab for specimen collection.

Actim Oy

Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 06430030990615
• NIH Device Record Key: 7c9fad6a-4b68-4a70-9b02-8a929f7c9e57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Actim PROM
• Version Model Number: 30821ETUS
• Company DUNS: 368646046
• Company Name: Actim Oy
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430030990608 [Package]; Contains: 06430030990714; Package: 10 tests kit box [10 Units]; In Commercial Distribution
GS1	06430030990615 [Package]; Contains: 06430030990714; Package: 20 tests kit box [20 Units]; In Commercial Distribution
GS1	06430030990714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123986

FDA Product Code

• OAM: Immunoassay, Insulin-Like Growth Factor Binding Protein-1

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-05
• Device Publish Date: 2019-02-28

Devices Manufactured by Actim Oy

• 06430030990622 - Actim PROM Controls: 2019-12-05 The Actim PROM Controls kit consists of one of each of the following components: 1. Actim PROM Negative Control (0 μg/L) 2. Act
• 06430030990615 - Actim PROM: 2019-12-05Actim PROM test pouch. Each pouch includes: - One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solution contains bovine serum albumin (BSA), protease inhibitors and preservatives. - One dipstick in a sealed aluminum foil pouch with desiccant. - One sterile polyester swab for specimen collection.
• 06430030990615 - Actim PROM: 2019-12-05 Actim PROM test pouch. Each pouch includes: - One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solutio