Axis® Homocysteine EIA FHCY100
GUDID 05055845400015
The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The d
AXIS-SHIELD DIAGNOSTICS LIMITED
Homocysteine IVD, reagent| Primary Device ID | 05055845400015 |
| NIH Device Record Key | 7b9542d0-ee61-4f74-9296-75043b177572 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Axis® Homocysteine EIA |
| Version Model Number | FHCY100 |
| Catalog Number | FHCY100 |
| 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 | true |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055845400015 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K980907
FDA Product Code
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-13 |
Devices Manufactured by AXIS-SHIELD DIAGNOSTICS LIMITED
| 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 | 2018-07-06The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The d |
| 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 | 2018-07-06 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 |
Trademark Results [Axis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AXIS 98859871 not registered Live/Pending |
AXIS Composites LLC 2024-11-18 |
 AXIS 98748873 not registered Live/Pending |
The Tiffen Company, LLC 2024-09-13 |
 AXIS 98625811 not registered Live/Pending |
Alexander Andrew, Inc. 2024-06-29 |
 AXIS 98408491 not registered Live/Pending |
ERCO GmbH 2024-02-16 |
 AXIS 98403895 not registered Live/Pending |
Axis Legal Counsel PC 2024-02-13 |
 AXIS 98235434 not registered Live/Pending |
Ortho Systems d/b/a Ovation Medical, Inc. 2023-10-23 |
 AXIS 98100213 not registered Live/Pending |
Aperture, LLC 2023-07-25 |
 AXIS 97908211 not registered Live/Pending |
AXIS GROUP VENTURES, LLC 2023-04-26 |
 AXIS 97878076 not registered Live/Pending |
Nexcam, Inc. 2023-04-07 |
 AXIS 97822017 not registered Live/Pending |
R & B South Sisters LLC 2023-03-03 |
 AXIS 97813960 not registered Live/Pending |
ORIGIN Engineering LLC 2023-02-27 |
 AXIS 97720076 not registered Live/Pending |
Milwaukee Electric Tool Corporation 2022-12-15 |
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