Actim PROM Controls

GUDID 06430030990622

The Actim PROM Controls kit consists of one of each of the following components: 1. Actim PROM Negative Control (0 μg/L) 2. Actim PROM Low Positive Control (40 μg/L) 3. Actim PROM High Positive Control (250 μg/L) 4. Actim Reconstitution Solution 5. Instructions for use

Actim Oy

Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, control
Primary Device ID06430030990622
NIH Device Record Keyf76486d6-7dac-4cef-873f-96d8d2d4dcab
Commercial Distribution StatusIn Commercial Distribution
Brand NameActim PROM Controls
Version Model Number30800ETUS
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
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106430030990622 [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 Controls2019-12-05The Actim PROM Controls kit consists of one of each of the following components: 1. Actim PROM Negative Control (0 μg/L) 2. Actim PROM Low Positive Control (40 μg/L) 3. Actim PROM High Positive Control (250 μg/L) 4. Actim Reconstitution Solution 5. Instructions for use
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 PROM2019-12-05 Actim PROM test pouch. Each pouch includes: - One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solutio

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