Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)
FDA 510(k) K212778 · Abbott Molecular, Inc.
Submission
- Device name
- Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)
- Applicant
- Abbott Molecular, Inc.
Des Plaines, IL, US - Received
- September 1, 2021
- Decision date
- July 15, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QLX – Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3183
- Specialty
- Microbiology
A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) using specified specimen processing, amplification, and detection instrumentation. The test is intended for use as an aid in the management of transplant…
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Questions and answers
When was Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) cleared by the FDA?
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (K212778) received a 510(k) decision of Substantially Equivalent on July 15, 2022, 317 days after the submission was received.
What is the product code of K212778?
The FDA product code is QLX – Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna, a Class II (moderate risk) device regulated under 21 CFR 866.3183.