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 ID06430030990615
NIH Device Record Key7c9fad6a-4b68-4a70-9b02-8a929f7c9e57
Commercial Distribution StatusIn Commercial Distribution
Brand NameActim PROM
Version Model Number30821ETUS
Company DUNS368646046
Company NameActim Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106430030990608 [Package]
Contains: 06430030990714
Package: 10 tests kit box [10 Units]
In Commercial Distribution
GS106430030990615 [Package]
Contains: 06430030990714
Package: 20 tests kit box [20 Units]
In Commercial Distribution
GS106430030990714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAMImmunoassay, Insulin-Like Growth Factor Binding Protein-1

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-05
Device Publish Date2019-02-28

Devices Manufactured by Actim Oy

06430030990622 - Actim PROM Controls2019-12-05 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 PROM2019-12-05Actim 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 PROM2019-12-05 Actim PROM test pouch. Each pouch includes: - One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solutio

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.