geneticsignatures.comEasyScreen Gastrointestinal Parasite Detection Kit
Genetic Signatures Limited
GENETIC SIGNATURES LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011781554 | 3011781554 | GENETIC SIGNATURES LIMITED | 1 | N | 2026-01-01 | 7 Eliza St Newtown New South Wales AU 2042 |
| 3031814323 | 3031814323 | GENETIC SIGNATURES US LTD. | 1 | Y | 2026-01-01 | 1124 W Carson St MRL Building - Floor 3 Torrance CA US 90502 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 09351179000003 | EasyScreen™ Sample Processing Kit - The EasyScreen™ Sample Processing Kit (SP012) is designed to rapidly isolate nucleic acids (DNA and RNA) from clinical samples via an automated purification system. Reagents are supplied to convert all nucleic acids into 3base™ sequences and to perform the subsequent purification on supported platforms (Genetic Signatures GS1). The purified nucleic acids are compatible with the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). This kit includes all reagents required to take a sample from the specimen, lyse any microorganisms, convert the nucleic acid into 3base™ form and purify the nucleic acids using magnetic beads. This kit is designed to be used in hospital and pathology laboratories or similar by trained personnel. This kit does not produce any results, but it is a necessary requirement for the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). | +61298707580 | northamerica@geneticsignatures.com |
| 09351179000188 | EasyScreen™ Sample Processing Kit - The EasyScreen™ Sample Processing Kit (SP008B) is designed to rapidly isolate nucleic acids (DNA and RNA) from clinical samples via an automated purification system. Reagents are supplied to convert all nucleic acids into 3base™ sequences and to perform the subsequent purification on supported platforms (Genetic Signatures GS1). The purified nucleic acids are compatible with the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). This kit includes all reagents required to take a sample from the specimen, lyse any microorganisms, convert the nucleic acid into 3base™ form and purify the nucleic acids using magnetic beads. This kit is designed to be used in hospital and pathology laboratories or similar by trained personnel. This kit does not produce any results, but it is a necessary requirement for the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). | +61298707580 | northamerica@geneticsignatures.com |
| 09351179000225 | EasyScreen™ Sample Processing Kit - The EasyScreen™ Sample Processing Kit (SP001) is a kit that contains reagents to isolate, sodium bisulphite treat and purify nucleic acids from clinical specimens or bacterial cultures. The nucleic acids can then be used with compatible EasyScreen™ Detection Kits for various microorganisms. | +61298707580 | northamerica@geneticsignatures.com |
| 09351179001161 | EasyScreen™ Gastrointestinal Parasite Detection Kit - The EasyScreen™ Gastrointestinal Parasite Detection Kit is intended for use as an aid in the diagnosis of gastrointestinal illness by qualitative detection of Gastrointestinal Parasites from stool of patients with diarrhoea. | +61298707580 | northamerica@geneticsignatures.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 183784 | 1765750800 | K232672 | EasyScreen Gastrointestinal Parasite Detection Kit | PCH | 2024-05-29 |
| 183784 | 1197391904 | ||||
| 183784 | 1841725115 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PCH | 1 | 2024-05-29 |
PMN#
GUDID#
EasyScreen™ Sample Processing Kit - The EasyScreen™ Sample Processing Kit (SP001) is a kit that contains reagents to isolate, sodium bisulphite treat and purify nucleic acids from clinical specimens or bacterial cultures. The nucleic acids can then be used with compatible EasyScreen™ Detection Kits for various microorganisms.
2024-12-03
EasyScreen™ Sample Processing Kit - The EasyScreen™ Sample Processing Kit (SP012) is designed to rapidly isolate nucleic acids (DNA and RNA) from clinical samples via an automated purification system. Reagents are supplied to convert all nucleic acids into 3base™ sequences and to perform the subsequent purification on supported platforms (Genetic Signatures GS1). The purified nucleic acids are compatible with the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). This kit includes all reagents required to take a sample from the specimen, lyse any microorganisms, convert the nucleic acid into 3base™ form and purify the nucleic acids using magnetic beads. This kit is designed to be used in hospital and pathology laboratories or similar by trained personnel. This kit does not produce any results, but it is a necessary requirement for the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005).
2024-11-18
EasyScreen™ Sample Processing Kit - The EasyScreen™ Sample Processing Kit (SP008B) is designed to rapidly isolate nucleic acids (DNA and RNA) from clinical samples via an automated purification system. Reagents are supplied to convert all nucleic acids into 3base™ sequences and to perform the subsequent purification on supported platforms (Genetic Signatures GS1). The purified nucleic acids are compatible with the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). This kit includes all reagents required to take a sample from the specimen, lyse any microorganisms, convert the nucleic acid into 3base™ form and purify the nucleic acids using magnetic beads. This kit is designed to be used in hospital and pathology laboratories or similar by trained personnel. This kit does not produce any results, but it is a necessary requirement for the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005).
2024-06-18
EasyScreen™ Gastrointestinal Parasite Detection Kit - The EasyScreen™ Gastrointestinal Parasite Detection Kit is intended for use as an aid in the diagnosis of gastrointestinal illness by qualitative detection of Gastrointestinal Parasites from stool of patients with diarrhoea.
2024-06-18
EasyScreen™ Gastrointestinal Parasite PCR Positive Control - The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes.This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel.
2024-06-18