FDA Registration
Active
🇺🇸 United States
Carclo Technical Plastics - Latrobe
Reg #: 3007135420
·
FEI: 3007135420
·
Expires 2026
Products
8
Proprietary Names
14
Establishment Types
1
Classifications
8
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Registration Details
- Registration Name
- Carclo Technical Plastics - Latrobe
- Registration Number
- 3007135420
- FEI Number
- 3007135420
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 550 & 600 Depot St
- City
- Latrobe
- State
- PA
- ZIP
- 15650
- Country
- US
Owner / Operator
- Firm Name
- CARCLO TECHNICAL PLASTICS
- Operator Number
- 9020456
- Address
- 600 DEPOT ST., --
- City
- Latrobe
- State
- PA
- Postal Code
- 15650
- Country
- US
- Correspondent
- Brian Kochanski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 2025-09-08 |
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2025-12-31 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2025-08-19 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 1999-04-08 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-09-24 |
| Cuvette, Thermostated | JRI | Class 1 | Clinical Chemistry | No | 2025-08-19 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2025-09-24 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2025-09-23 |
Proprietary Names
Cuvette Array (PN 246100)
PN 82420 (SANI-SCOPE ASSEMBLY)
UNR KIT SAMPLE TIPS - 6480/PKG (10309547, 078-K139-01)
ACS SAMPLE CUP (10309545, PN 078-K137-01)
SN 10445570 (PN 757347 STM1 Pipette Assembly)
SN 10385209 (PN LMH15 Microsampling Insert)
SN 10385209 (PN 502534 Molded Adapter Insert)
ACS CUVETTE -32 CAVITY (10309546, PN 078-K138-01)
SN 10445063 (PN 758820 BD Cannula)
SN 10445074 (PN 758860 Control Cup / Sample Stratus Cardiac)
SN 10445044 (PN 755300 RXV1 Reaction Vessel Flanged)
SN 10445210 (PN 10445210 KS840 VISTA ALIQPLT)
SN 10282849 (PN 501805 30 Degree Molded Septum)
SN 10445040 (PN 717827 DSC5 Small Container Dimension)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)