Mainline Technology, Inc.
Ann Arbor, MI, US
Mainline Technology, Inc. appears in FDA device records in Ann Arbor, MI. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 9 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Mainline Technology, Inc. in 2003.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1018-2010 | Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test. | Lack of assurance of safety and efficacy: unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expirations dates. | Terminated | ||
| Z-0531-2009 | Mainline Confirms hCG urine pregnancy test, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 6008C. | Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. | Terminated | ||
| Z-0530-2009 | f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065. | Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. | Terminated | ||
| Z-0529-2009 | Mainline Confirms hCG Serum/Urine III, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-25. | Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. | Terminated | ||
| Z-0528-2009 | Mainline hCG Accuracy Check, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3c1001. | Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. | Terminated | ||
| Z-0527-2009 | Mainline Confirms III Serum/Urine control set, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-CTR. | Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. | Terminated | ||
| Z-0526-2009 | Mainline Confirms Strep A DOTS, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 4040. | Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. | Terminated | ||
| Z-0525-2009 | Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 and 3030-40. | Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. | Terminated | ||
| Z-2427-2008 | Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococcal antigen directly from throat swabs, Mainline Technology, Inc., Ann Arbor, MI; Cat. Nos. 3030-20 (20 test) and 3030-40 (40 test). | Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain