IMMULITE® 2000 Systems HCG L2KCG6
GUDID 00630414961149
HCG Total - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay| Primary Device ID | 00630414961149 |
| NIH Device Record Key | d8779129-4f1e-4b7b-b352-5dc94e1a7531 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMMULITE® 2000 Systems HCG |
| Version Model Number | 10381194 |
| Catalog Number | L2KCG6 |
| 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 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| 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 |
| 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 | 00630414961149 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K990222
FDA Product Code
| DHA | SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN |
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 HCG]
| 00630414961149 | HCG Total - IMMULITE - RGT - 600 Tests |
| 00630414961132 | HCG Total - IMMULITE - RGT - 200 Tests |
Trademark Results [IMMULITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMMULITE 74098401 1653588 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1990-09-19 |
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