IMMULITE® Systems TSH Calibration Verification Material TSH LTSCVM

GUDID 00630414979458

TSH CVM - IMMULITE - CONS

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control Thyroid stimulating hormone (TSH) IVD, control

• Primary Device ID: 00630414979458
• NIH Device Record Key: ba005d63-54ee-4d3d-afec-3f4d36caa130
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMULITE® Systems TSH Calibration Verification Material TSH
• Version Model Number: 10388157
• Catalog Number: LTSCVM
• 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: 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 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414979458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910981

FDA Product Code

• JLW: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

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

Devices Manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

• 00630414561226 - ADVIA Centaur® HBcT2: 2023-06-28 ADVIA Centaur® HBcT2
• 00630414210766 - ADVIA Centaur® HBcT2 Quality Control Kit: 2023-06-28 ADVIA Centaur® HBcT2
• 00630414604138 - Atellica IM HBcT2: 2023-06-28 HBc Total 2 (HBcT2) Atellica IM - RGT 100T
• 00630414604336 - Atellica IM HBcT2 QC: 2023-06-28 HBc Total 2 (HBcT2) Atellica IM - CLT 2 x 2 x 7.0mL
• 00630414000138 - IMMULITE 2000 rBet v 2 Specific Allergen: 2022-09-20 rBet v 2 Alleren
• 00630414006246 - IMMULITE 2000 rMal d 1 Specific Allergen: 2022-09-20 rMal d 1 Allergen
• 00630414006253 - IMMULITE 2000 rPru av 3 Specific Allergen: 2022-09-20 rPru av 3 Allergen
• 00630414006277 - IMMULITE 2000 rPru av 4 Specific Allergen: 2022-09-20 rPru av 4 Allergen