FDA product code LIN: Antisera, Conjugated Fluorescent, Cytomegalovirus
LIN is the FDA product code for antisera, conjugated fluorescent, cytomegalovirus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel. FDA has cleared 17 510(k) submissions under LIN, from 13 different applicants. The average 510(k) review took 142 days (median 119).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Device class | Class II |
| Regulation | 21 CFR 866.3175 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LIN clearance
Top LIN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biotest Diagnostics Corp. | 2 | 1999-07-12 |
| Baxter Healthcare Corp | 2 | 1990-10-16 |
| Immuno Concepts, Inc. | 2 | 1989-07-14 |
| Bartels Immunodiagnostic Supplies, Inc. | 2 | 1986-05-13 |
| Diagnostic Hybrids, Inc. | 1 | 2008-06-13 |
8 more applicants have LIN clearances. See the full list in Caduvo.
Most recent LIN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081164 | Diagnostic Hybrids, Inc. | D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT | 2008-06-13 | 50 |
| K983762 | Organon Teknika Corp. | NUCLISENS CMV PP67 | 1999-09-15 | 324 |
| K991650 | Biotest Diagnostics Corp. | CMV BRITE TURBO KIT | 1999-07-12 | 60 |
| K951821 | Light Diagnostics | CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | 1996-06-07 | 414 |
| K951550 | Biotest Diagnostics Corp. | CMV BRITE ANTIGENEMIA TEST KIT | 1996-01-30 | 301 |
Recalls for LIN devices
openFDA lists no recalls for product code LIN.
Frequently asked questions
What is FDA product code LIN?
LIN is the FDA product code for antisera, conjugated fluorescent, cytomegalovirus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel.
What device class is LIN?
Class II, regulation 21 CFR 866.3175. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIN?
Across 17 cleared submissions the average was 142 days from receipt to decision (median 119).
Which companies have the most LIN clearances?
Biotest Diagnostics Corp. (2); Baxter Healthcare Corp (2); Immuno Concepts, Inc. (2); Bartels Immunodiagnostic Supplies, Inc. (2); Diagnostic Hybrids, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LIN
- Run a recall and safety report across every LIN manufacturer
- Watch product code LIN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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