Identity
- Trade Name
- Erythrocyte Lysis Solution FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- Erythrocyte Lysis Solution is a simple pretreatment for heavily blood-stained amniotic fluid and bone marrow samples which quickly removes heavy red blood cell (erythrocyte) contamination. Unlike many similar products used in molecular biology that lyse red blood cells, this product is extremely gentle in its action and is specially suited for cytogenetic cell culture work. It is well documented that high concentrations of red blood cells inhibit growth of cells from amniotic fluid by restricting colony size. FDA UDI
- Model / Reference
- GGS - JL009 FDA UDI
- Description
- Erythrocyte Lysis Solution is a simple pretreatment for heavily blood-stained amniotic fluid and bone marrow samples which quickly removes heavy red blood cell (erythrocyte) contamination. Unlike many similar products used in molecular biology that lyse red blood cells, this product is extremely gentle in its action and is specially suited for cytogenetic cell culture work. It is well documented that high concentrations of red blood cells inhibit growth of cells from amniotic fluid by restricting colony size. FDA UDI
Identifiers
- Catalog Number
- GGS - JL009 FDA UDI
- Primary DI / UDI-DI
- 05060174130038 FDA UDI
- FDA Product Code
- KIQ FDA UDI
- GMDN Term
- Assay development analyte-specific reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.2260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assay development analyte-specific reagent IVD
Erythrocyte Lysis Solution by Genial Helix Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Genial Helix Ltd
Sources (1)
- FDA UDI 7ab0afbd-bd79-4125-a932-27c972245b55 34 fields · synced May 30, 2026