Primary Device ID | 05055845400046 |
NIH Device Record Key | 63f8bc2a-341b-4295-9462-346baec81c21 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Axis-Shield Active-B12 (Holotranscobalamin) EIA |
Version Model Number | FMABT100 |
Catalog Number | FMABT100 |
Company DUNS | 229062427 |
Company Name | AXIS-SHIELD DIAGNOSTICS 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 | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +441382422000 |
MDL-AXD-Product-Support@alere. | |
Phone | +441382422000 |
MDL-AXD-Product-Support@alere.com | |
Phone | +441382422000 |
MDL-AXD-Product-Support@alere.com | |
Phone | +441382422000 |
MDL-AXD-Product-Support@alere.com | |
Phone | +441382422000 |
MDL-AXD-Product-Support@alere.com | |
Phone | +441382422000 |
MDL-AXD-Product-Support@alere.com | |
Phone | +441382422000 |
MDL-AXD-Product-Support@alere.com | |
Phone | +441382422000 |
MDL-AXD-Product-Support@alere.com | |
Phone | +441382422000 |
MDL-AXD-Product-Support@alere.com | |
Phone | +441382422000 |
MDL-AXD-Product-Support@alere.com | |
Phone | +441382422000 |
MDL-AXD-Product-Support@alere.com | |
Phone | +441382422000 |
MDL-AXD-Product-Support@alere.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05055845400046 [Primary] |
CDD | Radioassay, Vitamin B12 |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-02 |
05055845400008 - Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptid | 2018-07-06 The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of |
05055845400015 - Axis® Homocysteine EIA | 2018-07-06 The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human |
05055845400022 - Axis-Shield Homocysteine Controls | 2018-07-06 The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitati |
05055845400046 - Axis-Shield Active-B12 (Holotranscobalamin) EIA | 2018-07-06The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) |
05055845400046 - Axis-Shield Active-B12 (Holotranscobalamin) EIA | 2018-07-06 The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holot |
05055845400084 - 3-Reagent Homocysteine Assay for SYNCHRON UniCel | 2018-07-06 The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total hom |
05055845400169 - Axis-Shield Liquid Stable (LS) 2-Part Homocysteine | 2018-07-06 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in |
05055845400176 - Axis-Shield Liquid Stable (LS) 2-Part Homocysteine | 2018-07-06 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in |
05055845400183 - Axis-Shield Liquid Stable (LS) 2-Part Homocysteine | 2018-07-06 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in |