spectraldx.comEndotoxin Activity Assay (EAA)
Spectral Medical Inc.
Spectral Medical Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9617857 | 3000058367 | Spectral Medical Inc. | 1 | N | 2026-01-01 | 135 The West Mall, Unit 2 TORONTO Ontario CA M9C 1C2 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B173840070 | Smart Line TL Tube Luminometer - Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the <esc> key are all you need to operate the luminometer. Menus and parameters for functions that are not automated, are selected via these softkeys. The display shows the menu items, the actionsperformed and the user prompts.The luminometer includes an internal reading device for chip cards. Measurement protocols are saved on this chip card. During this procedure the user is prompted step by step to place the required tubes into the instrument for measurement. This ensures a high level of automation and standardization of the measurement process. | 18884264264 | gguadagni@spectraldx.com |
| B17384018010 | Sirius 2 Tube Luminometer - The Sirius 2 Tube Luminometer is a highly sensitive and compact stand-alone single tube luminometer. The touchscreen on the control unit is all that is needed to operate the luminometer. Menus and parameters for functions that are not automated, are selected via the touchscreen on the control unit. The display shows the menu items, the actions performed, and the user prompts. The luminometer is capable of reading USB keys. Measurement protocols may be saved on USB keys. During a procedure, the user is prompted step-by-step to place the required tubes into the instrument for measurement. This ensures the standardization of the measurement process. The Sirius 2 is designed for the detection of chemi- and bioluminescence. | 647-646-0637 | nali@spectraldx.com |
| B173EAAST200 | Endotoxin Activity Assay (EAA) - The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens. | 18884264264 | shung@spectraldx.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 17940 | 1396612317 | K183176 | Endotoxin Activity Assay (EAA) | NGS | 2019-03-12 |
| 17940 | 1438814709 | DEN030002 | ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE | NGS | 2003-06-16 |
| 17940 | 1200773756 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NGS | 2 | 2019-03-12 |
PMN#
SAM CRRT Unit, SAM Cassette CRRT
Spectral Medical Inc.
GUDID#
Endotoxin Activity Assay (EAA) - The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens.
2018-01-09
Smart Line TL Tube Luminometer - Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the <esc> key are all you need to operate the luminometer. Menus and parameters for functions that are not automated, are selected via these softkeys. The display shows the menu items, the actionsperformed and the user prompts.The luminometer includes an internal reading device for chip cards. Measurement protocols are saved on this chip card. During this procedure the user is prompted step by step to place the required tubes into the instrument for measurement. This ensures a high level of automation and standardization of the measurement process.
2019-03-14
Sirius 2 Tube Luminometer - The Sirius 2 Tube Luminometer is a highly sensitive and compact stand-alone single tube luminometer. The touchscreen on the control unit is all that is needed to operate the luminometer. Menus and parameters for functions that are not automated, are selected via the touchscreen on the control unit. The display shows the menu items, the actions performed, and the user prompts. The luminometer is capable of reading USB keys. Measurement protocols may be saved on USB keys. During a procedure, the user is prompted step-by-step to place the required tubes into the instrument for measurement. This ensures the standardization of the measurement process. The Sirius 2 is designed for the detection of chemi- and bioluminescence.
2025-03-21
Endotoxin Activity Assay (EAA) - The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens.
2021-02-18
SAMI RRT Cassette - The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure.The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
2018-03-05
SAMI RRT - The SAMI RRT Unit is a software controlled device that performs the following functions:- Primes the disposable cassette automatically.- Pumps blood through the blood flow path of the disposable cassette.- Delivers anticoagulant into the blood flow path.- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapyin use.- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies.- Controls the patient fluid removal or plasma loss according to the therapy in use.- Monitors the system and alerts the operator to abnormal situations through alarms.The SAMI RRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the Cassette tubing set.
2018-02-22
SAMI Hemofiltration Cassette - The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
2019-02-22
SAMI RRT Cassette - The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
2018-03-05
Cassette CRRT - The Cassette for CRRT is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. The total length of the arterial and venous tubing lines are below: - Arterial patient connection line: 71 inches - Arterial dialyzer line: 20 inches - Venous patient connection line: 22 inches - Venous dialyzer line: 79 inches
2018-03-05
Cassette Hemofiltration - The HF Cassette for CRRT is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. The total length of the arterial and venous tubing lines are below: -Arterial patient connection line: 71 inches -Arterial dialyzer line: 20 inches -Venous patient connection line: 22 inches -Venous dialyzer line: 79 inches
2019-02-22
SAMI CRRT Unit - The SAMI CRRT Unit is a software controlled device that performs the following functions: - Primes the CRRT disposable cassette automatically. - Pumps
2018-02-22