Atellica IM CHIV 10995459

GUDID 00630414600390

CHIV - Atellica IM - RGT - 100T

Siemens Healthcare Diagnostics Inc.

HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00630414600390
• NIH Device Record Key: 40766460-c4bc-48b2-9d62-ef4ed1d57d1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atellica IM CHIV
• Version Model Number: 10995459
• Catalog Number: 10995459
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics Inc.
• 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: false
• 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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414600390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP140103

FDA Product Code

• MZF: Test, HIV detection

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: 2019-09-30
• Device Publish Date: 2018-12-21

On-Brand Devices [Atellica IM CHIV]

• 00630414600390: CHIV - Atellica IM - RGT - 100T
• 00630414301280: CHIV - Atellica IM - RGT - 100T