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HemaTechnologies ESR Control

FDA UDI

Class II (US FDA UDI)

by Airscan, Inc.

Identity

Trade Name
HemaTechnologies ESR Control FDA UDI
Generic Name
Erythrocyte sedimentation rate (ESR) IVD, control FDA UDI
Model / Reference
ESRC20014 FDA UDI

Identifiers

Catalog Number
ESRC20014 FDA UDI
Primary DI / UDI-DI
00868556000246 FDA UDI
510(k) Number
K991876 FDA UDI
FDA Product Code
JPK FDA UDI
GMDN Term
Erythrocyte sedimentation rate (ESR) IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.8625 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Erythrocyte sedimentation rate (ESR) IVD, control

HemaTechnologies ESR Control by Airscan, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Erythrocyte sedimentation rate (ESR) IVD, control.

Cleared under the same submission

K991876 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Airscan, Inc.

Sources (1)

  • FDA UDI e7773917-4ef6-46eb-93e2-cf0a445916db 35 fields · synced May 30, 2026