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MedTest DX Lactate Dehydrogenase / BS480

FDA UDI

Class II (US FDA UDI)

by Medtest DX

Identity

Trade Name
MedTest DX Lactate Dehydrogenase / BS480 FDA UDI
Generic Name
Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry FDA UDI
Device Name
Lactate Dehydrogenase, for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum using the Mindray BS-480 analyzer. Size: 4 x 40 ml, 4 x 10 ml. FDA UDI
Model / Reference
LDH480 FDA UDI
Description
Lactate Dehydrogenase, for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum using the Mindray BS-480 analyzer. Size: 4 x 40 ml, 4 x 10 ml. FDA UDI

Identifiers

Catalog Number
LDH480 FDA UDI
Primary DI / UDI-DI
00817439020987 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
Not 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

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

MedTest DX Lactate Dehydrogenase / BS480 by Medtest DX — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtest DX

Sources (1)

  • FDA UDI 92da26b1-c885-4b0a-b2d9-85546c757b6c 37 fields · synced May 30, 2026