Abbott Rapid Dx North America, LLC
Lake Mary, FL, US
Abbott Rapid Dx North America, LLC appears in FDA device records in Lake Mary, FL. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Abbott Rapid Dx North America, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
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510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006984151 | 3006984151 | Abbott Rapid Dx North America, LLC | 1101 Greenwood Blvd Unit 4001, Lake Mary, FL 32746 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2111-2011 | Clearview iFOB, Clearview - Clearview iFOB Return Mailer(accessory) Product Part Number: 8117KCV Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices | Potential for false negatives test results and negative/faint positive controls | Terminated | ||
| Z-2110-2011 | Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory) Product Part Number: 8116KCV Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices | Potential for false negatives test results and negative/faint positive controls | Terminated | ||
| Z-2109-2011 | Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8115KCV (25 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices | Potential for false negatives test results and negative/faint positive controls | Terminated | ||
| Z-2108-2011 | Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (25 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8114KCV (25 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices | Potential for false negatives test results and negative/faint positive controls | Terminated | ||
| Z-2107-2011 | Clearview iFOB, Clearview - Sample Kit (5 Test)Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8112KCV (5 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices | Potential for false negatives test results and negative/faint positive controls | Terminated | ||
| Z-2106-2011 | Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8111KCV (30 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices | Potential for false negatives test results and negative/faint positive controls | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain