- Nucleocapsid antigen from SARS‑CoV‑2 may be detected within the first 5 days of symptom onset.
- 25 tests per kit: devices, extraction reagent capsules, sterile swabs; includes 1 positive and 1 negative control swab and package insert.
- Visual read; results in ~15 minutes.
- Authorized for point‑of‑care use under FDA EUA (CLIA‑waived settings permitted per EUA).
- SKU:
- 1186780
- QTY Per Sell:
- 1
- Number of Tests:
- 25 Tests
- Reading Type:
- Visual Read
- Sample Type:
- Nasopharyngeal Swab Sample
- Manufacturer:
- LifeSign (Status™ brand). ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- Manufacturer Part Number:
- 33225. ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- Regulatory / EUA:
- Authorized under FDA EUA for point‑of‑care use. ([henryschein.com](https://www.henryschein.com/us-en/medical/p/laboratory/rapid-diagnostic-test-kit/status-covid-19-flu-a-b/1399188?utm_source=openai))
- CLIA Classification:
- CLIA‑Waived when used per instructions. ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- Intended Use (concise):
- Simultaneous qualitative detection of SARS‑CoV‑2, Influenza A & B nucleocapsid antigens from nasal/NP swabs within 5 days of symptom onset. ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- Time to Results:
- Approx. 15 minutes. ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- Clinical Performance (selected):
- COVID‑19: ~93.9% sens / 100% spec
- Flu A: ~91.4% sens / 95.7% spec
- Flu B: ~87.6% sens / 95.9% spec
([nhddistribution.com](https://nhddistribution.com/products/status%E2%84%A2-covid-19-flu-a-b-test?utm_source=openai))- Test Method / Format:
- Lateral flow immunoassay, colloidal gold; visually read cassette. ([aurorabiomed.com](https://www.aurorabiomed.com/product/status-covid-19-flu-ab-rapid-antigen-test/?utm_source=openai))
- Kit Contents (short):
- 25 test devices
- 25 extraction reagent capsules
- 25 sterile swabs + pos/neg control swabs
([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))- Storage Conditions:
- Store at 2–30°C (35–86°F). ([verseadiagnostics.com](https://verseadiagnostics.com/products/covid-19-flu-test-status?utm_source=openai))
- Sample Handling / Notes:
- Specimens must be at room temp before assay; follow IFU for QC/controls. ([ciamedical.com](https://www.ciamedical.com/lifesign-33225-eua-authorized-covid-19-flu-a-and-b-25-tests_01?utm_source=openai))
- Country of Origin:
- United States (as listed by distributors). ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- CPT / Billing Codes (common):
- COVID‑19: 87811QW
- Flu A/B: 87804QW (may vary)
([nhddistribution.com](https://nhddistribution.com/products/status%E2%84%A2-covid-19-flu-a-b-test?utm_source=openai))- Shelf Life / Dating (note):
- Check expiration on box/individual tests; distributors ship with ≥60 days dating when noted. ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- Storage & Shipping Notes:
- Ship and store within manufacturer temp range; do not freeze. ([verseadiagnostics.com](https://verseadiagnostics.com/products/covid-19-flu-test-status?utm_source=openai))
- SKU:
- 1186780
- QTY Per Sell:
- 1
- Number of Tests:
- 25 Tests
- Reading Type:
- Visual Read
- Sample Type:
- Nasopharyngeal Swab Sample
- ic__sync_id:
- 1
- ic__id:
- 1256
- Manufacturer:
- LifeSign (Status™ brand). ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- Manufacturer Part Number:
- 33225. ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- Regulatory / EUA:
- Authorized under FDA EUA for point‑of‑care use. ([henryschein.com](https://www.henryschein.com/us-en/medical/p/laboratory/rapid-diagnostic-test-kit/status-covid-19-flu-a-b/1399188?utm_source=openai))
- CLIA Classification:
- CLIA‑Waived when used per instructions. ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- Intended Use (concise):
- Simultaneous qualitative detection of SARS‑CoV‑2, Influenza A & B nucleocapsid antigens from nasal/NP swabs within 5 days of symptom onset. ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- Time to Results:
- Approx. 15 minutes. ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- Clinical Performance (selected):
- COVID‑19: ~93.9% sens / 100% spec
- Flu A: ~91.4% sens / 95.7% spec
- Flu B: ~87.6% sens / 95.9% spec
([nhddistribution.com](https://nhddistribution.com/products/status%E2%84%A2-covid-19-flu-a-b-test?utm_source=openai))- Test Method / Format:
- Lateral flow immunoassay, colloidal gold; visually read cassette. ([aurorabiomed.com](https://www.aurorabiomed.com/product/status-covid-19-flu-ab-rapid-antigen-test/?utm_source=openai))
- Kit Contents (short):
- 25 test devices
- 25 extraction reagent capsules
- 25 sterile swabs + pos/neg control swabs
([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))- Storage Conditions:
- Store at 2–30°C (35–86°F). ([verseadiagnostics.com](https://verseadiagnostics.com/products/covid-19-flu-test-status?utm_source=openai))
- Sample Handling / Notes:
- Specimens must be at room temp before assay; follow IFU for QC/controls. ([ciamedical.com](https://www.ciamedical.com/lifesign-33225-eua-authorized-covid-19-flu-a-and-b-25-tests_01?utm_source=openai))
- Country of Origin:
- United States (as listed by distributors). ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- CPT / Billing Codes (common):
- COVID‑19: 87811QW
- Flu A/B: 87804QW (may vary)
([nhddistribution.com](https://nhddistribution.com/products/status%E2%84%A2-covid-19-flu-a-b-test?utm_source=openai))- Shelf Life / Dating (note):
- Check expiration on box/individual tests; distributors ship with ≥60 days dating when noted. ([mms.mckesson.com](https://mms.mckesson.com/product/1186780/LifeSign-33225?utm_source=openai))
- Storage & Shipping Notes:
- Ship and store within manufacturer temp range; do not freeze. ([verseadiagnostics.com](https://verseadiagnostics.com/products/covid-19-flu-test-status?utm_source=openai))
