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IDG/Sanzay

FDA UDI

Class II (US FDA UDI)

by IDG/SANZAY Corporation

Identity

Trade Name
IDG/Sanzay FDA UDI
Generic Name
Lactate dehydrogenase 5 (LDH-5) isoenzyme IVD, reagent FDA UDI
Device Name
Lactate Dehydrogenase LS (LDH-L) liquid reagent is intended to use for the In Vitro quantitative kinetic determination of Lactate Dehydrogenase activity in serum. FDA UDI
Model / Reference
1 FDA UDI
Description
Lactate Dehydrogenase LS (LDH-L) liquid reagent is intended to use for the In Vitro quantitative kinetic determination of Lactate Dehydrogenase activity in serum. FDA UDI

Identifiers

Catalog Number
C343 FDA UDI
Primary DI / UDI-DI
00850053916137 FDA UDI
510(k) Number
K874848 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

Yes

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

Dimensions & Sizes

Size
Total Volume — 150 Milliliter FDA UDI
Total Volume — 300 Milliliter FDA UDI
Total Volume — 1 Liter FDA UDI

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

IDG/Sanzay by IDG/SANZAY Corporation — 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.

Cleared under the same submission

K874848 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
IDG/SANZAY Corporation

Sources (1)

  • FDA UDI 8ab91ee7-6336-454f-9c86-67dcb4f4c97d 37 fields · synced Jun 6, 2026