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Erythropoietin ELISA

FDA UDI

Class II (US FDA UDI)

by American Laboratory Products Company

Identity

Trade Name
Erythropoietin ELISA FDA UDI
Generic Name
Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
The EPO ELISA is intended for use in the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias. FDA UDI
Model / Reference
21-EPOHU-E01 FDA UDI
Description
The EPO ELISA is intended for use in the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias. FDA UDI

Identifiers

Catalog Number
21-EPOHU-E01 FDA UDI
Primary DI / UDI-DI
B24221EPOHUE010 FDA UDI
510(k) Number
K992799 FDA UDI
FDA Product Code
GGT FDA UDI
GMDN Term
Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay 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

No

FDA UDI

Category: Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay

Erythropoietin ELISA by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay.

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
American Laboratory Products Company

Sources (1)

  • FDA UDI 99201864-0ee6-43bc-8793-db555beaeefe 37 fields · synced Jun 8, 2026