Product code GMP
- Device name
- Antisera, Control For Nontreponemal Tests
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3820
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K980638 | ADI SYPHILIS RPR LIQUID CONTROLS | Ampcor Diagnostics, Inc. | 1998-07-06 |
| K961998 | QUALITROL SYPHSERO CONTROL SET | Consolidated Technologies, Inc. | 1996-08-08 |
| K955143 | RPR LIQUID CONTROLS | Remel, L.P. | 1996-07-30 |
| K885298 | VISUWELL REAGIN TEST 960 TEST KIT | Allelix Diagnostics, Inc. | 1989-03-15 |
| K875180 | V-TREND RPRL CARD TEST | Texas Immunology, Inc. | 1988-02-04 |
| K851504 | VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 | Ncs Diagnostics, Inc. | 1985-08-19 |
| K843741 | RPR TEST REDITEST | Biokit USA, Inc. | 1984-10-25 |
| K812425 | BECKMAN R.PR CONTROL SERUM SET | Beckman Instruments, Inc. | 1981-09-23 |
| K810119 | CONTROL SERUMS FOR NONTREPONEMAL TEST | Hillside Acres, Inc. | 1981-02-09 |
Related GUDID Devices#
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|---|---|---|---|
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| 00816057021796 | ASI RPR Card Test for Syphilis | ARLINGTON SCIENTIFIC, INC. | 2023-12-19 |
| B224V611 | VDRL CONTROL SERUM KIT | CENOGENICS CORPORATION | 2021-05-27 |
| 00613647001622 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2019-04-18 |
| 00613647001615 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2019-04-18 |
| 00613647001608 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2019-04-18 |
| 00613647001592 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2019-04-18 |
| 00613647001585 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2019-04-18 |
| 00613647001578 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2019-04-08 |
| 00613647000977 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2019-04-08 |
| 10613647000844 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-06-27 |
| 10613647000912 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-06-27 |
| 10613647000905 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-06-27 |
| 10613647000899 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-06-27 |
| 10613647000882 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-06-27 |
| 10613647000875 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-06-27 |
| 10613647000868 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-06-27 |
| 10613647000851 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-06-27 |
| 10613647000837 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-06-27 |
| 20885380114417 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-15 |
| 20885380114394 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-15 |
| 20885380114387 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-15 |
| 20885380114370 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-15 |
| 10885380114403 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-15 |
| 10885380114410 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-15 |
| 20885380114400 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-15 |
| 00816057020690 | ASI RPR Card Test for Syphilis | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020706 | ASI RPR Card Test for Syphilis | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020713 | ASI RPR Card Test for Syphilis | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 30382902767092 | BD Macro-Vue™ RPR™ Card Test Control Card | BECTON, DICKINSON AND COMPANY | 2016-05-19 |