Primary Device ID | 00893038002890 |
NIH Device Record Key | 9a61b78c-e709-415a-87ed-2e6677cbac59 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cholestech LDX™ |
Version Model Number | 97987 |
Catalog Number | 97987 |
Company DUNS | 194854949 |
Company Name | ALERE SAN DIEGO, INC. |
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 | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.com | |
Phone | +18774417440 |
USproductsupport@abbott.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 |
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 | 00893038002890 [Primary] |
CHH | Enzymatic Esterase--Oxidase, Cholesterol |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-28 |
Device Publish Date | 2023-12-20 |
00893038002036 | Cholestech LDX™ Multianalyte Controls (2 X 250µL) |
00893038002029 | Cholestech LDX™ Multianalyte Calibration Verification |
00893038002012 | Cholestech LDX™ Multianalyte Controls (2 X 2ml) |
00893038002944 | Cholestech LDX™ Optics Check Cassette |
00893038002937 | Cholestech LDX™ Lipid Profile GLU |
00893038002920 | Alere Cholestech LDX™ TC HDL GLU |
00893038002913 | Cholestech LDX™ Lipid Profile |
00893038002906 | Cholestech LDX™ TC GLU |
00893038002890 | Cholestech LDX™ TC HDL |
00893038002883 | Cholestech LDX™ TC |
00810039380512 | Cholestech LDX™ Analyzer |
00810039380307 | Cholestech LDX™ Analyzer |