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Mission Plus Hemoglobin (Hb) Monitoring System

FDA UDI

Class II (US FDA UDI)

by ACON Laboratories, Inc.

Identity

Trade Name
Mission Plus Hemoglobin (Hb) Monitoring System FDA UDI
Generic Name
Haemoglobin analyser IVD, point-of-care FDA UDI
Device Name
Hb Meter, vial of 2 Optical Verifiers FDA UDI
Model / Reference
C112-3041 FDA UDI
Description
Hb Meter, vial of 2 Optical Verifiers FDA UDI

Identifiers

Primary DI / UDI-DI
00682607611126 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Haemoglobin analyser IVD, point-of-care

Mission Plus Hemoglobin (Hb) Monitoring System by ACON Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ACON Laboratories, Inc.

Sources (1)

  • FDA UDI c0d3b2af-17c9-4957-97e8-c8759ecd17b1 35 fields · synced Jun 9, 2026