Antisera, Control For Nontreponemal Tests
The Control Antisera for Nontreponemal Tests is a reference serum used to validate the performance of nontreponemal serological tests for syphilis, ensuring accurate and reliable screening results. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GMP, regulated under 21 CFR 866.3820 in the Microbiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- GMP
- Device Class
- FDA class 2
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K980638 | ADI SYPHILIS RPR LIQUID CONTROLS | Jul 06, 1998 | Substantially Equivalent | Ampcor Diagnostics, Inc. |
| K961998 | QUALITROL SYPHSERO CONTROL SET | Aug 08, 1996 | Substantially Equivalent | Consolidated Technologies, Inc. |
| K955143 | RPR LIQUID CONTROLS | Jul 30, 1996 | Substantially Equivalent | Remel, L.P. |
| K885298 | VISUWELL REAGIN TEST 960 TEST KIT | Mar 15, 1989 | Substantially Equivalent | Allelix Diagnostics, Inc. |
| K875180 | V-TREND RPRL CARD TEST | Feb 04, 1988 | Substantially Equivalent | Texas Immunology, Inc. |
| K851504 | VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 | Aug 19, 1985 | Substantially Equivalent | Ncs Diagnostics, Inc. |
| K843741 | RPR TEST REDITEST | Oct 25, 1984 | Substantially Equivalent | Biokit USA, Inc. |
| K812425 | BECKMAN R.PR CONTROL SERUM SET | Sep 23, 1981 | Substantially Equivalent | Beckman Instruments, Inc. |
| K810119 | CONTROL SERUMS FOR NONTREPONEMAL TEST | Feb 09, 1981 | Substantially Equivalent | Hillside Acres, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.