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AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome FDA UDI
- Generic Name
- SARS-CoV-2 nucleic acid IVD, control FDA UDI
- Device Name
- AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome (Positive and Negative member-5 X 1.5 ml) FDA UDI
- Model / Reference
- 0505-0159 FDA UDI
- Description
- AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome (Positive and Negative member-5 X 1.5 ml) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816784020987 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- SARS-CoV-2 nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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
AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome by LGC Clinical Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as SARS-CoV-2 nucleic acid IVD, control.
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- Exact Diagnostics — Exact Diagnostics · Class I
- Helix Elite™ Molecular Standards: Synthetic Standard — MICROBIOLOGICS, INC. · Class I
- ID NOW COVID-19 2.0 Control Swab Kit — Alere Scarborough, 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 I | Pending data |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Sources (1)
- FDA UDI 5b4a77de-0e1b-496a-b7d7-545d6830b5ae 34 fields · synced Jun 9, 2026