Product code DAD
- Device name
- Haptoglobin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5460
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993480 | K-ASSAY HAPTOGLOBIN | Kamiya Biomedical Co. | 1999-11-24 |
| K972639 | TINA-QUANT HAPTOGLOBIN | Boehringer Mannheim Corp. | 1998-01-09 |
| K964301 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 |
| K963286 | IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT | Beckman Instruments, Inc. | 1996-10-07 |
| K952593 | N/T PROTEIN CONTROL SY/L, M AND H | Behring Diagnostics, Inc. | 1995-07-17 |
| K915829 | IL TEST(TM) HAPTOGLOBIN (HPT) | Instrumentation Laboratory CO | 1992-07-29 |
| K911898 | RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT | Reagents Applications, Inc. | 1991-05-08 |
| K890562 | SPQ(TM) ANTIBODY REAGENT SET II FOR HPT | Atlantic Antibodies | 1989-02-22 |
| K873866 | HAPTOGLOBIN | Unipath , Ltd. | 1987-10-20 |
| K872717 | QM300 HAPTOGLOBIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-07-21 |
| K864512 | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO | Cooper Biomedical, Inc. | 1987-02-13 |
| K850584 | SPQ TEST SYSTEM FOR HAPTOGLOBIN | Applications Lab | 1985-03-05 |
| K840404 | DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO | Tago, Inc. | 1984-03-09 |
| K831957 | DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB | Kent Laboratories, Inc. | 1983-07-18 |
| K812494 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO | Dako Corp. | 1981-09-23 |
| K801433 | HAPTOGLOBIN NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | 1980-07-08 |
| K772245 | HAPTOGLOBIN NEPHELOMETRIC ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 |
| K760144 | SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID | Oxford Laboratories, Inc. | 1976-07-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414305080 | Atellica CH HAPT2 | Siemens Healthcare Diagnostics Inc. | 2023-08-28 |
| 00630414610986 | Atellica CH HAPT2 | Siemens Healthcare Diagnostics Inc. | 2023-08-28 |
| 00380740169879 | Alinity | ABBOTT IRELAND | 2021-05-13 |
| 00380740169886 | ARCHITECT | ABBOTT IRELAND | 2021-03-19 |
| 07613336140772 | Tina-quant Haptoglobin ver.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740150686 | Alinity | Abbott GmbH | 2019-07-08 |
| 05055273203806 | HAPTOGLOBIN (HP) | RANDOX LABORATORIES LIMITED | 2019-06-03 |
| 06970291985161 | Haptoglobin Kit (Immunoturbidimetric Method) | Medicalsystem Biotechnology Co., Ltd. | 2019-03-07 |
| 00630414210827 | Atellica™ CH Hapt | Siemens Healthcare Diagnostics Inc. | 2018-12-08 |
| 15099590010621 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 00630414491356 | ADVIA® Chemistry HAPT Haptoglobin Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768006111 | DImension Vista® Haptoglobin Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 05051700017626 | Optilite Haptoglobin Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700016094 | Human Haptoglobin Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| B1761120 | Antiserum to Human Haptoglobin | KENT LABORATORIES INC | 2016-09-24 |
| 00630414506005 | ADVIA® Chemistry HAPT Haptoglobin Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630928620 | Tinaquant Haptoglobin ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630916580 | Tinaquant Haptoglobin ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630906765 | Tinaquant Haptoglobin | Roche Diagnostics GmbH | 2016-09-20 |
| 00816426020153 | K-ASSAY® Haptoglobin Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |
| 10758750002283 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |
| 15099590224431 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590230456 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 00380740019693 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |