Identity
- Trade Name
- Atellica IM PRGE FDA UDI
- Generic Name
- Progesterone IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Progesterone (PRGE) Atellica IM - RGT 450T FDA UDI
- Model / Reference
- 10995659 FDA UDI
- Description
- Progesterone (PRGE) Atellica IM - RGT 450T FDA UDI
Identifiers
- Catalog Number
- 10995659 FDA UDI
- Primary DI / UDI-DI
- 00630414599779 FDA UDI
- 510(k) Number
- K932955 FDA UDI
- FDA Product Code
- JLS FDA UDI
- GMDN Term
- Progesterone IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1620 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: Progesterone IVD, kit, chemiluminescent immunoassay
Atellica IM PRGE by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Progesterone IVD, kit, chemiluminescent immunoassay.
- Progesterone (serum) — DRG International, Inc. · Class I
- VITROS — Ortho-Clinical Diagnostics · Class I
- IMMULITE® 2000 Systems PRG Progesterone — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Progesterone Luminescence Immunoassay — IBL International GmbH · Class I
- Progesterone AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class I
- Alinity — ABBOTT IRELAND · Class I
- Elecsys Progesterone III — Roche Diagnostics Corp. · Class I
- iFlash-Progesterone — Shenzhen YHLO Biotech Co., Ltd. · Class I
Cleared under the same submission
K932955 also covers:
- ADVIA Centaur® Calibrator E — Siemens Healthcare Diagnostics
- ADVIA Centaur® Immunoassay Systems PRGE MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® PRGE — Siemens Healthcare Diagnostics
- ADVIA Centaur® PRGE +E — Siemens Healthcare Diagnostics
- ADVIA Centaur® Progesterone (PRGE) — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems ACS:180® Systems Calibrator E — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems CAL Calibrator E — Siemens Healthcare Diagnostics
- Atellica IM Calibrator E — Siemens Healthcare Diagnostics
- Atellica IM Calibrator E — Siemens Healthcare Diagnostics
- Atellica IM Calibrator E — Siemens Healthcare Diagnostics
- Atellica IM PRGE — Siemens Healthcare Diagnostics
- Atellica IM PRGE — Siemens Healthcare Diagnostics
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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 484e6a55-0fa3-4699-8f9e-48bcc35c2c32 37 fields · synced May 30, 2026