FETALSCREEN™II
GUDID 10758750006144
FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation.
ALBA BIOSCIENCE LIMITED
Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foetal blood group genotyping IVD, reagent Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control Foeto-maternal haemorrhage/Kleihauer test IVD, control| Primary Device ID | 10758750006144 |
| NIH Device Record Key | 906f7e41-dc9d-480b-a37f-3a2a8226c3ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FETALSCREEN™II |
| Version Model Number | Z488 |
| Company DUNS | 516536641 |
| Company Name | ALBA BIOSCIENCE LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10758750006144 [Primary] |
FDA Product Code
| MTI | Kit, Cell Screening, Fetal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-03-31 |
| Device Publish Date | 2017-03-29 |
Devices Manufactured by ALBA BIOSCIENCE LIMITED
| 05060242477959 - ALBA Elution Kit | 2023-10-23 The ALBA Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detectio |
| 10758750006144 - FETALSCREEN™II | 2022-03-31FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation. |
| 10758750006144 - FETALSCREEN™II | 2022-03-31 FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation. |
| 10758750013005 - ORTHOTM Sera Anti-Fya | 2022-03-31 The Anti-Fya reagent (Anti-FY1) is for the qualitative in vitro detection of human Fya positive red blood cells by the indirect |
| 10758750013012 - ORTHOTM Sera Anti-Fyb | 2022-03-31 The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of human Fyb positive red blood cells by the indirect |
| 10758750013029 - ORTHOTM Sera Anti-Jka | 2022-03-31 The Anti-Jka reagent (Anti-JK1) is for the qualitative in vitro detection of human Jka positive red blood cells by the direct ag |
| 10758750013036 - ORTHOTM Sera Anti-Jkb | 2022-03-31 The Anti-Jkb reagent (Anti-JK2) is for the qualitative in vitro detection of human Jkb positive red blood cells by the direct ag |
| 10758750013043 - ORTHOTM Sera Anti-S | 2022-03-31 The Anti-S reagent (Anti-MNS3) is for the qualitative in vitro detection of human S positive red blood cells by the indirect ant |
| 10758750013050 - ORTHOTM Sera Anti-s | 2022-03-31 The Anti-s reagent (Anti-MNS4) is for the qualitative in vitro detection of human s positive red blood cells by the indirect ant |
Trademark Results [FETALSCREEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FETALSCREEN 77603919 3758767 Live/Registered |
CRIMSON U.S. ASSETS LLC 2008-10-30 |
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