FDA Registration
Active
🇺🇸 United States
Caplugs, Inc.
Reg #: 2016673
·
FEI: 2016673
·
Expires 2026
Products
12
Proprietary Names
27
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- Caplugs, Inc.
- Registration Number
- 2016673
- FEI Number
- 2016673
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18704 S Ferris Pl
- City
- Rancho Dominguez
- State
- CA
- ZIP
- 90220
- Country
- US
Regulatory Submissions
- 510(k) Number
- K833469
Owner / Operator
- Firm Name
- Caplugs, Inc.
- Operator Number
- 10050609
- Address
- 2150 Elmwood Ave
- City
- Buffalo
- State
- NY
- Postal Code
- 14207
- Country
- US
- Correspondent
- Christine Koch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2015-12-08 |
| Adsorbents, Ion-Exchange | DKO | Class 1 | Clinical Chemistry | No | 2015-12-08 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2016-10-18 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2015-12-08 |
| Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen | JKH | Class 1 | Clinical Chemistry | No | 2015-12-08 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2015-12-08 |
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 2015-12-08 |
| Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | JJC | Class 1 | Clinical Chemistry | No | 2015-12-08 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2015-12-08 |
| Device, Parasite Concentration | LKS | Class 1 | Microbiology | No | 2015-12-08 |
| Device, Microtiter Diluting/Dispensing | JTC | Class 1 | Microbiology | No | 2015-12-08 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2015-12-08 |
Proprietary Names
Microscope slides & cover glass
Treated plastic slides - sterile
Disposable Columns
Universal Columns/Mini Columns
Surety Columns and Sera-Separa Columns
Sputocol Sputum Collection System
Collection/Transport Containers - sterile
Embedding rings/processing & Embedding cassettes
Hematology Dilution Vials
Pipet Tips - OEM replacement Tips
Transfer Pipets with Measuring Function
Inoculating Loops
Sterile Culture Tubes
Serum sample cups
Piggyback Serum Cups/transport container
Disposables for use with Abbott TDx
Histoware Prefilled Vials - non sterile
Specimen Storage Container- non sterile
Transport Vials
Pathology Specimen Containers - non sterile
Centrifuge Tubes
Collection/transport Containers - non sterile
Histoware Specimen Containers - non sterile
FPC Fecal Parasite Concentrators
95 pin inoculator - sterile
Pap-Fix Plus Jars for In-situ Hybridization
Pap- Fix Plus Jars
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device