Primary Device ID | 00850053916212 |
NIH Device Record Key | 64997c9e-7922-4ee4-8607-6badfbafb309 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IDG/Sanzay |
Version Model Number | 1 |
Catalog Number | HCC1 |
Company DUNS | 948875013 |
Company Name | IDG/SANZAY Corporation |
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 | 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 | false |
OTC Over-The-Counter | true |
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 | 00850053916212 [Primary] |
GGN | Plasma, Coagulation Control |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-01-22 |
Device Publish Date | 2024-01-12 |
00850053916007 | Albumin reagent is used for the quantitative determination of albumin concentration in human ser |
00850053916021 | For the quantitative determination of alanine aminotransferase in serum used in routine examinat |
00850053916014 | For the quantitative determination of alkaline phosphatase in human serum. |
00850053916038 | For the quantitative determination of aspartate aminotransferase (AST) in human serum. The reage |
00850053916229 | The IDG Control Level 2 Low Abnormal is intended for use for quality assurance of in vitro diagn |
00850053916212 | The IDG Control Level 1 Normal is intended for use in quality assurance of in vitro diagnostic c |
00850053916199 | The IDG APTT-EA reagent is an in vitro diagnostic assay intended for use in determining activate |
00850053916182 | The IDG PT-HS reagent is an in vitro diagnostic assay intended for use in performing the one sta |
00850053916175 | The IDG HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High |
00850053916168 | For the in vitro quantitative determination of Uric Acid in serum. |
00850053916151 | For the in vitro quantitative determination of Triglycerides in serum or plasma. |
00850053916144 | For the quantitative determination of total protein concentration in human serum. |
00850053916137 | Lactate Dehydrogenase LS (LDH-L) liquid reagent is intended to use for the In Vitro quantitative |
00850053916120 | Inorganic phosphorus (UV method) reagent is for the quantitative determination of inorganic phos |
00850053916076 | For the quantitative determination of calcium concentration in serum or plasma. |
00850053916250 | The HDL-LDL calibrator is used to establish the value of high density lipoprotein cholesterol an |
00850053916243 | For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accura |
00850053916236 | For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accura |
00850053916113 | For the In Vitro quantitative determination of glucose in human serum or plasma. |
00850053916267 | The Multi-Analyte Chemistry calibrator is for use as a calibrator of IDG Clinical chemistry assa |
00850053916205 | Calcium Chloride 0.020 M is a reagent for use only in the in vitro determination of Prothrombin |