Identity
- Trade Name
- SARS CoV-2 Controls (SARS-CoV-2) FDA UDI
- Generic Name
- SARS-CoV-2 total antibody IVD, control FDA UDI
- Device Name
- "SARS-CoV-2 (Severe acute respiratory syndrome coronavirus) Negative/Non-Reactive Control SARS-CoV-2 Negative/Non-Reactive Control is intended for use with in vitro assays for determination of Total antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus). SARS-CoV-2 Negative/Non-Reactive Control is unassayed without target values and is suitable for use on various analysers. SARS-CoV-2 Negative/Non-Reactive Control is useful in determining the precision of testing systems and allows performance monitoring of multiple test systems. SARS-CoV-2 (Severe acute respiratory syndrome coronavirus) Positive/Reactive Control SARS-CoV-2 Positive/Reactive Control is intended for use with in vitro assays for determination of Total antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus). SARS-CoV-2 Positive/Reactive Control is unassayed without target values and is suitable for use on various analysers. SARS-CoV-2 Negative/Non-Reactive Control is useful in determining the precision of testing systems and allows performance monitoring of multiple test systems." FDA UDI
- Model / Reference
- COV10460 FDA UDI
- Description
- "SARS-CoV-2 (Severe acute respiratory syndrome coronavirus) Negative/Non-Reactive Control SARS-CoV-2 Negative/Non-Reactive Control is intended for use with in vitro assays for determination of Total antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus). SARS-CoV-2 Negative/Non-Reactive Control is unassayed without target values and is suitable for use on various analysers. SARS-CoV-2 Negative/Non-Reactive Control is useful in determining the precision of testing systems and allows performance monitoring of multiple test systems. SARS-CoV-2 (Severe acute respiratory syndrome coronavirus) Positive/Reactive Control SARS-CoV-2 Positive/Reactive Control is intended for use with in vitro assays for determination of Total antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus). SARS-CoV-2 Positive/Reactive Control is unassayed without target values and is suitable for use on various analysers. SARS-CoV-2 Negative/Non-Reactive Control is useful in determining the precision of testing systems and allows performance monitoring of multiple test systems." FDA UDI
Identifiers
- Catalog Number
- COV10460 FDA UDI
- Primary DI / UDI-DI
- 05055273216936 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- SARS-CoV-2 total antibody 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
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
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 total antibody IVD, control
SARS CoV-2 Controls (SARS-CoV-2) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 109cc556-5eaf-4aeb-b018-bab81279a3ab 36 fields · synced Jun 1, 2026