Identity
- Trade Name
- Accula SARS CoV-2 Control Kit FDA UDI
- Generic Name
- SARS-CoV-2 nucleic acid IVD, control FDA UDI
- Device Name
- The Accula™ SARS-CoV-2 Control Kit provides positive and negative control swabs for use with the Accula™ SARS-CoV-2 Test. Positive swabs are coated with DNA Based Synthetic Oligo. The High Positive Controls contain a level of oligo sufficient to provide a positive result when used with the Accula SARS-CoV-2 Test. The Low Positive Controls contain a lower level of oligo, near the limit of detection of the test, but is sufficient to provide a positive result when used with the Accula™ SARS-CoV-2 Test. When used for quality control in the Accula SARS-CoV-2 Test, these controls are useful as an aid in verifying test and operator performance. FDA UDI
- Model / Reference
- COV4100-1 FDA UDI
- Description
- The Accula™ SARS-CoV-2 Control Kit provides positive and negative control swabs for use with the Accula™ SARS-CoV-2 Test. Positive swabs are coated with DNA Based Synthetic Oligo. The High Positive Controls contain a level of oligo sufficient to provide a positive result when used with the Accula SARS-CoV-2 Test. The Low Positive Controls contain a lower level of oligo, near the limit of detection of the test, but is sufficient to provide a positive result when used with the Accula™ SARS-CoV-2 Test. When used for quality control in the Accula SARS-CoV-2 Test, these controls are useful as an aid in verifying test and operator performance. FDA UDI
Identifiers
- Catalog Number
- COV4100-1 FDA UDI
- Primary DI / UDI-DI
- B540COV4100010 FDA UDI
- GMDN Term
- SARS-CoV-2 nucleic acid IVD, control FDA UDI
Classification
- 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: SARS-CoV-2 nucleic acid IVD, control
Accula SARS CoV-2 Control Kit by Mesa Biotech, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SARS-CoV-2 nucleic acid IVD, control.
- Aptima® — Hologic, Inc. · Class II
- RealTime — Abbott Molecular · N
- ACCURUN® — LGC Clinical Diagnostics, Inc.
- NATtrol™ — ZeptoMetrix LLC · Class I
- NATtrol™ — ZeptoMetrix LLC · Class I
- Simplexa COVID-19 Direct — DiaSorin Molecular LLC · Class II
- AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome — LGC Clinical Diagnostics, Inc. · Class I
- Exact Diagnostics — Exact Diagnostics · Class I
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mesa Biotech, Inc.
Sources (1)
- FDA UDI 42dfd75b-96c6-4dca-8dd9-3eb877bb69a1 36 fields · synced May 30, 2026