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Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge HCG
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge HCG FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests FDA UDI
- Model / Reference
- 10444913 FDA UDI
- Description
- Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests FDA UDI
Identifiers
- Catalog Number
- RF430 FDA UDI
- Primary DI / UDI-DI
- 00842768013850 FDA UDI
- 510(k) Number
- K970387 FDA UDI
- FDA Product Code
- DHA FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)
Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge HCG by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA).
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Cleared under the same submission
K970387 also covers:
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
Sources (1)
- FDA UDI 92f12cab-4230-4cb7-ac8c-f2372fdcf606 37 fields · synced May 31, 2026