Identity
- Trade Name
- LDH-L FDA UDI
- Generic Name
- Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry FDA UDI
- Device Name
- For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. FDA UDI
- Model / Reference
- 12-L7572-100 FDA UDI
- Description
- For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. FDA UDI
Identifiers
- Catalog Number
- 12-L7572-100 FDA UDI
- Primary DI / UDI-DI
- 00811727013620 FDA UDI
- 510(k) Number
- K973589 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
Ldh-L by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Alinity — Abbott · Class II
- LDH-L SL — VITALSCIENTIFIC
- Lactate dehydrogenase liquid acc to IFCC — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K973589 also covers:
- Pointe Lactate Dehydrogenase Reagent — POINTE SCIENTIFIC, INC.
- Pointe Lactate Dehydrogenase Reagent — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. LD — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. LD — POINTE SCIENTIFIC, INC.
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI cf557025-e0c5-4f43-9049-516c1869f6bd 37 fields · synced Jun 1, 2026