Last synced on 20 December 2024 at 11:05 pm

Yersinia Spp. Reagents

Page Type
Product Code
Definition
Yersinia spp. reagents are devices that consist of Serological Reagents and Nucleic Acid Amplification Reagents to differentiate Yersinia spp. and presumptively identify Yersinia pestis (Y. pestis) from cultured isolates or clinical specimens. They are indicated for use as an aid in the laboratory of diagnosis of plague.
Physical State
Kit includes primers, probes, enzymes and specific controls for amplification and are designed for use with specific instrument systems.
Technical Method
Nucleic Acid Amplification Reagents
Target Area
Systemic, Whole blood, sputum,
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
U
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OIH is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.

Yersinia Spp. Reagents

Page Type
Product Code
Definition
Yersinia spp. reagents are devices that consist of Serological Reagents and Nucleic Acid Amplification Reagents to differentiate Yersinia spp. and presumptively identify Yersinia pestis (Y. pestis) from cultured isolates or clinical specimens. They are indicated for use as an aid in the laboratory of diagnosis of plague.
Physical State
Kit includes primers, probes, enzymes and specific controls for amplification and are designed for use with specific instrument systems.
Technical Method
Nucleic Acid Amplification Reagents
Target Area
Systemic, Whole blood, sputum,
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
U
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OIH is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.