MONOLISA ANTI-HBC EIA
FDA premarket approval P060031/S004 · decided 2010-11-23
Approval details
- PMA number
- P060031
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MONOLISA ANTI-HBC EIA
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Bio-Rad Laboratories, Inc.
- Date received
- 2010-06-17
- Decision date
- 2010-11-23
- Days to decision
- 159 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIO-RAD LABORATORIES IN WOODINVILLE, WASHINGTON.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (K181661) | Bio-Rad Laboratories, Inc. | 2019-02-13 |
| Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software (K171664) | Bio-Rad Laboratories, Inc. | 2017-09-13 |
| D-10 Hemoglobin A1c Program (K161687) | Bio-Rad Laboratories, Inc. | 2016-10-14 |
| D-100 HbA1c, D-100 HbA1c Calibrator Pack (K151321) | Bio-Rad Laboratories, Inc. | 2015-12-09 |
| VARIANT II TURBO HbA1c Kit - 2.0 (K142448) | Bio-Rad Laboratories, Inc. | 2015-03-24 |
| VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM (K140801) | Bio-Rad Laboratories, Inc. | 2014-06-25 |
| BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI (K130053) | Bio-Rad Laboratories, Inc. | 2013-09-19 |
| LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK (K130963) | Bio-Rad Laboratories, Inc. | 2013-05-06 |