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DiaSpect Tm

FDA UDI

Class II (US FDA UDI)

by EKF-diagnostic GmbH

Identity

Trade Name
DiaSpect Tm FDA UDI
Generic Name
Haemoglobin analyser IVD, point-of-care FDA UDI
Device Name
For the quantitative determination of hemoglobin in whole blood. FDA UDI
Model / Reference
7049-0013-0264 FDA UDI
Description
For the quantitative determination of hemoglobin in whole blood. FDA UDI

Identifiers

Catalog Number
900-001 FDA UDI
Primary DI / UDI-DI
04048534002165 FDA UDI
FDA Product Code
GKR FDA UDI
GMDN Term
Haemoglobin analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5620 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

Yes

FDA UDI

Over-the-Counter

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Haemoglobin analyser IVD, point-of-care

DiaSpect Tm by EKF-diagnostic GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemoglobin analyser IVD, point-of-care.

Cleared under the same submission

BK200520 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
EKF-diagnostic GmbH

Sources (1)

  • FDA UDI 96e5af96-520b-4776-b98f-28366623f4f2 37 fields · synced Jun 8, 2026