Identity
- Trade Name
- Revogene Strep A FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The revogene Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens. The revogene Strep A assay is intended for use as an aid in the diagnosis of the Group A Streptococcus infection. The revogene Strep A assay is intended for use in hospital, reference or state laboratory settings. FDA UDI
- Model / Reference
- 410400 FDA UDI
- Description
- The revogene Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens. The revogene Strep A assay is intended for use as an aid in the diagnosis of the Group A Streptococcus infection. The revogene Strep A assay is intended for use in hospital, reference or state laboratory settings. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840733102325 FDA UDI
- FDA Product Code
- PGX FDA UDIOOI FDA UDI
- GMDN Term
- Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.2680 FDA UDI862.2570 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Revogene Strep A by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT).
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- Xpert Xpress Strep A — CEPHEID · Class II
- Xpert Xpress Strep A — CEPHEID · Class II
- Simplexa™ Group A Strep Direct — DiaSorin Molecular LLC · Class II
- Alethia™ Group A Streptococcus — MERIDIAN BIOSCIENCE, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI f116db21-ae98-46f5-8665-ac695698e253 35 fields · synced May 30, 2026