Identity
- Trade Name
- IMMULITE / IMMULITE® 1000 Systems CAL Calcitonin FDA UDI
- Generic Name
- Calcitonin IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Calcitonin - IMMULITE - RGT - 100 Tests FDA UDI
- Model / Reference
- 10381401 FDA UDI
- Description
- Calcitonin - IMMULITE - RGT - 100 Tests FDA UDI
Identifiers
- Catalog Number
- LKCL1 FDA UDI
- Primary DI / UDI-DI
- 00630414963730 FDA UDI
- 510(k) Number
- K023304 FDA UDI
- FDA Product Code
- JKR FDA UDI
- GMDN Term
- Calcitonin IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1140 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Calcitonin IVD, kit, chemiluminescent immunoassay
IMMULITE / IMMULITE® 1000 Systems CAL Calcitonin by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Calcitonin IVD, kit, chemiluminescent immunoassay.
- Elecsys Calcitonin Immunoassay — Roche Diagnostics Corp. · Class II
- Calcitonin AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
- Atellica IM Calcitonin — Siemens Healthcare Diagnostics · Class II
- Elecsys Calcitonin — Roche Diagnostics Corp. · Class II
- Calcitonin AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class II
- ADVIA Centaur Calcitonin — Siemens Healthcare Diagnostics · Class II
- Calcitonin AccuLite CLIA Test System -192 Wells — MONOBIND, INC. · Class II
- Calcitonin AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 16858994-108c-4a0d-9fb1-c5947135d297 37 fields · synced May 29, 2026