IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta. (UDI Z-1420-2017)
Manufactured by Siemens Healthcare Diagnostics, Inc
Device Regulatory Overview
The IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta. (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc. This product is indexed under FDA Product Code / Category Classification LKPW1 kit lot 0245 LKPW1 kit lot 0246 LKPW1 kit lot 0247 LKPW1 kit lot 0248 LKPW1 kit lot 0249 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
- LKPW1 kit lot 0245 LKPW1 kit lot 0246 LKPW1 kit lot 0247 LKPW1 kit lot 0248 LKPW1 kit lot 0249
- Device Name
- IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
- Database Sync Date
- 2026-08-09 10:06:47
Full Regulatory Attributes
🔒 Token Gated
{
"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 IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.?
The registered manufacturer of record for IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta. is Siemens Healthcare Diagnostics, Inc.
What is the Primary UDI-DI identifier for IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-1420-2017.
What classification code is assigned to this device?
This device is registered under product classification code LKPW1 kit lot 0245 LKPW1 kit lot 0246 LKPW1 kit lot 0247 LKPW1 kit lot 0248 LKPW1 kit lot 0249.
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