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Staph ID/R Blood Culture Panel

FDA UDI

Class II (US FDA UDI)

by Great Basin Scientific, Inc.

Identity

Trade Name
Staph ID/R Blood Culture Panel FDA UDI
Generic Name
MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Model / Reference
GBSIDR-10 FDA UDI

Identifiers

Catalog Number
GBSIDR-10 FDA UDI
Primary DI / UDI-DI
B178GBSIDR100 FDA UDI
FDA Product Code
OOI FDA UDI
PAM FDA UDI
GMDN Term
MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
866.3365 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: MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)Multiple Staphylococcus bacterial species culture isolate identification IVD, kitMRSA nucleic acid IVD, kit, nucleic acid technique (NAT)MRSE nucleic acid detection IVD, kit, nucleic acid technique (NAT)

Staph ID/R Blood Culture Panel by Great Basin Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRSA 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 44f2789a-d3ac-42f9-b8b8-8301106e4e3c 35 fields · synced Jun 6, 2026