Diamedix 720-540
Diamedix 720-540 is a Class I device made by Diamedix Corp., cleared under FDA 510(k) K974552 on 28 Jan 1998 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020303), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817273020303 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK974552 | Date28 Jan 1998 | StatusActive |
Official records
- AccessGUDID record 00817273020303
- FDA 510(k) database K974552
Across registries
- FDA 510(k) K974552 decided 28 Jan 1998 Active
- FDA GUDID UDI-DI 00817273020303 listed 20 Sep 2016 Listed
Recalls
-
- Terminated Z-0607-2009
Possible false-negative test results: The Sample A Diluent Lot # 50768 assigned to Is-Measles IgG Lot #'s 41108 and 41108B has higher conductivity than normal, which can sporadically interfere with the MAGO Plus/Aptus sensing of and picking up of samples. As a result, if the sample is not picked up/processed, it could lead to the possibility of obtaining false negative results in some cases.
Timeline
- Cleared FDA 510(k) K974552
- Recall initiated FDA recalls Z-0607-2009
- Listed FDA GUDID 00817273020303
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diamedix
- Generic name
- Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)
- Model / reference
- 720-540
- Description
- "720-540 Mumps IgG Test Kit"
- Primary DI / UDI-DI
- 00817273020303
- 510(k) Number
- FDA product code
- LJB
- GMDN term
- Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)
- Device class
- Class I
- Regulation number
- 866.3520
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code LJB (Enzyme Linked Immunoabsorbent Assay, Rubeola Igg).
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- RUBEOLA IGM ELISA TEST by Gull Laboratories, Inc.
- QUANTA LITE RUBEOLA (MEASLES) IGG by Inova Diagnostics. Inc.