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ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents FDA UDI
- Generic Name
- Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry FDA UDI
- Device Name
- LDH P->L - ADVIA Chem. - RGT - 6x670 tests FDA UDI
- Model / Reference
- 10341129 FDA UDI
- Description
- LDH P->L - ADVIA Chem. - RGT - 6x670 tests FDA UDI
Identifiers
- Catalog Number
- 3030863 FDA UDI
- Primary DI / UDI-DI
- 00630414517445 FDA UDI
- FDA Product Code
- CFJ FDA UDI
- GMDN Term
- Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1440 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
Yes
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 lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry.
- Lactate dehydrogenase liquid acc to IFCC — Roche Diagnostics Corp. · Class II
- Lactate Dehydrogenase acc to IFCC ver2 — Roche Diagnostics Corp. · Class II
- LD opt. (LDH P-L) — Randox Laboratories, Ltd. · Class II
- Alinity — Abbott · Class II
- LD opt. (LDH L-P) — Randox Laboratories, Ltd. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Alinity — Abbott · Class II
- LDH-L SL — VITALSCIENTIFIC
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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 07799ba3-4655-49d7-9622-aefbb1dde9da 36 fields · synced Jun 6, 2026