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Phadebact Haemophilus Test

FDA UDI

Class II (US FDA UDI)

by Mkl Diagnostics AB

Identity

Trade Name
Phadebact Haemophilus Test FDA UDI
Generic Name
Haemophilus influenzae culture isolate antigen IVD, kit, agglutination FDA UDI
Model / Reference
10-5575-12 FDA UDI

Identifiers

Catalog Number
10-5575-12 FDA UDI
Primary DI / UDI-DI
07350049850115 FDA UDI
FDA Product Code
GRP FDA UDI
GMDN Term
Haemophilus influenzae culture isolate antigen IVD, kit, agglutination FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3300 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

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Haemophilus influenzae culture isolate antigen IVD, kit, agglutination

Phadebact Haemophilus Test by Mkl Diagnostics AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemophilus influenzae culture isolate antigen IVD, kit, agglutination.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mkl Diagnostics AB

Sources (1)

  • FDA UDI 9706ab44-7d7f-48c4-b3c0-9e8f2841ab01 35 fields · synced Jun 8, 2026