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Bordetella Direct Test

FDA UDI

Class II (US FDA UDI)

by Great Basin Scientific, Inc.

Identity

Trade Name
Bordetella Direct Test FDA UDI
Generic Name
Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
Bordetella Direct Test Cartridge FDA UDI
Model / Reference
GBBORD-10 FDA UDI
Description
Bordetella Direct Test Cartridge FDA UDI

Identifiers

Catalog Number
GBBORD-10 FDA UDI
Primary DI / UDI-DI
B178GBBORD100 FDA UDI
FDA Product Code
OOI FDA UDI
OZZ FDA UDI
GMDN Term
Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
866.3980 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

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: Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)

Bordetella Direct Test by Great Basin Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Great Basin Scientific, Inc.

Sources (1)

  • FDA UDI dfc7d2ba-b3cb-4b0f-a537-f07ce9ef030a 36 fields · synced May 30, 2026