IMMULITE® 2000 Systems FOL Folic Acid L2KFO2

GUDID 00630414961484

Folic Acid - IMMULITE - RGT - 200 Tests

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00630414961484
• NIH Device Record Key: 97c1103f-2cfa-4bd2-8330-5b6ba92a8caf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMULITE® 2000 Systems FOL Folic Acid
• Version Model Number: 10380911
• Catalog Number: L2KFO2
• Company DUNS: 296822794
• Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
• 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: false
• 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

Customer Support Contacts

• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

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
• 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	00630414961484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993254

FDA Product Code

• CGN: ACID, FOLIC, RADIOIMMUNOASSAY

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: 2016-09-24

On-Brand Devices [IMMULITE® 2000 Systems FOL Folic Acid]

• 00630414961491: Folic Acid - IMMULITE - RGT - 600 Tests
• 00630414961484: Folic Acid - IMMULITE - RGT - 200 Tests