Siemens ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test) (UDI Z-0397-2017)
Manufactured by Siemens Healthcare Diagnostics, Inc
Device Regulatory Overview
The Siemens ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test) (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc. This product is indexed under FDA Product Code / Category Classification All lot codes within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- N/A
- Product Code / EMDN
- All lot codes
- Device Name
- Siemens ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test)
- Database Sync Date
- 2026-08-09 10:06:45
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Siemens ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test)?
The registered manufacturer of record for Siemens ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test) is Siemens Healthcare Diagnostics, Inc.
What is the Primary UDI-DI identifier for Siemens ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0397-2017.
What classification code is assigned to this device?
This device is registered under product classification code All lot codes.
Similar Classification Devices (All lot codes)
- → Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
- → Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
Other Devices by Siemens Healthcare Diagnostics, Inc
- → Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
- → ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
- → ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum.
- → ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
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