Panels › Immunology › Product code DHB · Class 2
System, Test, Radioallergosorbent (Rast) Immunological
Regulation 866.5750
7510(k)s in 12 months (269 all time)
14recalls in 12 months (27 all time)
16recalls that name a 510(k)
Top companies in DHB
| Company | 510(k)s | Recalls |
|---|---|---|
| Pharmacia, Inc. | 39 | 0 |
| Diagnostic Products Corp. | 26 | 0 |
| Hycor Biomedical | 24 | 1 |
| Incstar Corp. | 25 | 0 |
| Phadia AB | 16 | 2 |
| Ventrex Laboratories, Inc. | 18 | 0 |
| Siemens Healthcare Diagnostics | 9 | 8 |
| Immuno Nuclear Corp. | 14 | 0 |
| 3M Company | 13 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 11 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Pollen Allergy Test Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Pet Allergy Test Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Food Intolerance Test Small Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Food Intolerance Test Medium Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Food Intolerance Test Large Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Allergy test Small Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Allergy Test IgE Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Food Sensitivity Test Small Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Food Sensitivity Test Medium Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Food Sensitivity Test Large Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Food Allergy Panel Test (IgE) Open, Classified |
DHB | None listed |
| Nov 13, 2025 | Siemens Healthcare Diagnostics, Inc. Food Panel 3 Specific Allergen;
Siemens Material Number (SMN): 10385891;
Catalog Number: FP3L4; Open, Classified |
DHB | K021208 |
| Nov 13, 2025 | Siemens Healthcare Diagnostics, Inc. 3gAllergy Specific IgE Universal Kit;
Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2);
Siemens Material Number (SMN): 10380875;
Catal Open, Classified |
DHB | K101572 |
| Nov 13, 2025 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Oak Mix Specific Allergen;
Siemens Material Number (SMN): 10386105;
Catalog Number: L2KUN6; Open, Classified |
DHB | K021206 |
| Dec 15, 2022 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan
Siemens Material Number (SMN): 10711939
For the quantitative measurement of allergen-specific IgE in human serum, as an aid in Open, Classified |
DHB | K101572 |
| Dec 15, 2022 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan
Siemens Material Number (SMN): 10380875
For the quantitative measurement of allergen-specific IgE in human serum, Open, Classified |
DHB | K101572 |
| Dec 15, 2022 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US.
Siemens Material Number (SMN): 10708840
For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quan Open, Classified |
DHB | K101572 |
| Jul 9, 2019 | Phadia Ab Phadia" 1000
Model # 12-3800-01
Product Usage:
The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all st Terminated |
DHB | K051218 |
| Jul 25, 2018 | Hycor Biomedical LLC HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA Open, Classified |
DHB | K081217 K941278 |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit Terminated |
DHB | K013134 |
| Dec 18, 2017 | Phadia US Inc ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016).
ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to b Terminated |
DHB | K051218 K993388 |
| Dec 18, 2017 | Phadia US Inc ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01).
ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be Terminated |
DHB | K051218 K993388 |
| Nov 20, 2017 | Phadia Ab Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version Terminated |
DHB | K151029 |
| Jul 5, 2017 | Phadia US Inc Phadia 1000 Instrument, Article Number 12-3800-01. Terminated |
DHB | K133404 K161899 |
| Jun 25, 2015 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD.
For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzer Terminated |
DHB | K013134 |
| Jan 12, 2015 | Phadia US Inc Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for Terminated |
DHB | K121156 K121463 +4 |
| Feb 7, 2013 | Hitachi Chemical Diagnostics Inc OPTIGEN Food 30; Catalog number: 85035. For allergen testing.
Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA.
Distributed by Theridiag, Cedex, France Terminated |
DHB | K051677 |
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