Diagnostic Hybrids, Inc.: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “Diagnostic Hybrids, Inc.” (first 1988, latest 2010), plus 1 De Novo decision, across 12 product codes in 3 review panels. Median 510(k) review time under this name: 78 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under QuidelOrtho, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KIR | Cells, Animal And Human, Cultured | 13 | 13 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 7 | 7 |
| GNW | Antisera, Cf, Influenza Virus A, B, C | 5 | 5 |
| OMG | Antisera, Fluorescent, Human Metapneumovirus | 3 | 3 |
| JZO | System, Test, Thyroid Autoantibody | 2 | 2 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 | 1 |
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 1 | 1 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | 1 | 1 |
| LIN | Antisera, Conjugated Fluorescent, Cytomegalovirus | 1 | 1 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 1 | 1 |
Plus 2 more product codes.
Review panels
- Microbiology (22)
- Pathology (13)
- Immunology (2)
Most recent Diagnostic Hybrids, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092229 | THYRETAIN TM TSI REPORTER BIOASSAY | JZO | 2010-05-18 | 299 |
| K093415 | D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT | GQS | 2009-12-23 | 51 |
| K093233 | D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT | OMG | 2009-12-04 | 51 |
| K092882 | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT | GNW | 2009-10-21 | 33 |
| K091171 | D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT | OMG | 2009-09-11 | 142 |
| K092300 | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | GNW | 2009-08-28 | 30 |
| K091753 | ELVIS HSV ID AND D3 TYPING TEST SYSTEM | GQL | 2009-08-28 | 73 |
| K083391 | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY | JZO | 2009-05-21 | 185 |
| K090073 | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT | OMG | 2009-03-06 | 53 |
| K081928 | D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT | LKT | 2008-12-23 | 169 |
26 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140004 | De Novo | Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | 2014-05-13 |
Recalls
9 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2017-04-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Diagnostic Hybrids, Inc. (a text match, not an official crosswalk):
- G0008 — Administration of influenza virus vaccine (via GNW)
- Q2039 — Influenza virus vaccine, not otherwise specified (via GNW)
- Q2034 — Influenza virus vaccine, split virus, for intramuscular use (agriflu) (via GNW)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Diagnostic Products Corp. (324 510(k)s)
- Diagnostic Systems Laboratories, Inc. (94 510(k)s)
- Diagnostic Chemicals, Ltd. (Usa) (77 510(k)s)
- Diagnostic Chemicals , Ltd. (66 510(k)s)
- Diagnostic Reagents, Inc. (66 510(k)s)
- Diagnostic Technology, Inc. (28 510(k)s)
- Diagnostic Solutions, Inc. (26 510(k)s)
- Diagnostic Ultrasound Corp. (16 510(k)s)
- Diagnostic Systems (14 510(k)s)
- Diagnostic Reagent Tech. (10 510(k)s)
- Diagnostic Specialties (8 510(k)s)
- Diagnostic Medical Instruments (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diagnostic Hybrids, Inc.?
FDA lists 36 510(k) clearances under the applicant name “Diagnostic Hybrids, Inc.” (first 1988, latest 2010), plus 1 De Novo decision, across 12 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Diagnostic Hybrids, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostic Hybrids, Inc. is 78 days.
Which FDA product codes appear under Diagnostic Hybrids, Inc.?
The most frequent FDA product codes under this applicant name are KIR (Cells, Animal And Human, Cultured, 13); GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2, 7); GNW (Antisera, Cf, Influenza Virus A, B, C, 5).
Next steps
- See all 36 Diagnostic Hybrids, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KIR, Diagnostic Hybrids, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.