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LDH Reagent Set

FDA UDI

Class II (US FDA UDI)

by Clinical Diagnostic Solutions, Inc.

Identity

Trade Name
LDH Reagent Set FDA UDI
Generic Name
Lactate dehydrogenase 5 (LDH-5) isoenzyme IVD, reagent FDA UDI
Device Name
For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Increased levels of LD are associated with myocardial infarction. Levels reach a maximum approximately 48 hours after the onset of pain and persist about ten days. The degree of elevation is of value in assessing the extent of damage and in developing a prognosis. LD elevations are also observed in liver disease, pernicious anemia, in some cases of renal disease, and in some cases of skeletal muscle trauma. FDA UDI
Model / Reference
R1 x 500mL, R2 x 125mL FDA UDI
Description
For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Increased levels of LD are associated with myocardial infarction. Levels reach a maximum approximately 48 hours after the onset of pain and persist about ten days. The degree of elevation is of value in assessing the extent of damage and in developing a prognosis. LD elevations are also observed in liver disease, pernicious anemia, in some cases of renal disease, and in some cases of skeletal muscle trauma. FDA UDI

Identifiers

Catalog Number
501-413 FDA UDI
Primary DI / UDI-DI
00812137012005 FDA UDI
FDA Product Code
CFJ FDA UDI
GMDN Term
Lactate dehydrogenase 5 (LDH-5) isoenzyme IVD, reagent 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

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: Lactate dehydrogenase 5 (LDH-5) isoenzyme IVD, reagent

LDH Reagent Set by Clinical Diagnostic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lactate dehydrogenase 5 (LDH-5) isoenzyme IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clinical Diagnostic Solutions, Inc.

Sources (1)

  • FDA UDI 04371e3e-0f00-4c0a-9eaa-bd9123c5623a 36 fields · synced May 30, 2026