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EPO (Erythropoietin) ELISA

FDA UDI

Class II (US FDA UDI)

by DRG Instruments Gesellschaft mit beschränkter Haftung

Identity

Trade Name
EPO (Erythropoietin) ELISA FDA UDI
Generic Name
Erythropoietin (EPO) IVD, reagent FDA UDI
Device Name
The EPO ELISA is intended for in vitro diagnostic use in the quantitative determination of Erythropoietin (EPO) in human serum FDA UDI
Model / Reference
EIA-3646 FDA UDI
Description
The EPO ELISA is intended for in vitro diagnostic use in the quantitative determination of Erythropoietin (EPO) in human serum FDA UDI

Identifiers

Catalog Number
EIA-3646 FDA UDI
Primary DI / UDI-DI
04048474036466 FDA UDI
510(k) Number
K992799 FDA UDI
FDA Product Code
GGT FDA UDI
GMDN Term
Erythropoietin (EPO) IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7250 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

Yes

FDA UDI

Category: Erythropoietin (EPO) IVD, reagent

EPO (Erythropoietin) ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Erythropoietin (EPO) IVD, reagent.

Cleared under the same submission

K992799 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DRG Instruments Gesellschaft mit beschränkter Haftung

Sources (1)

  • FDA UDI 2a09cfe0-4500-4c0f-8851-73a0e093525b 37 fields · synced Jun 8, 2026