Primary Device ID | 10722355003013 |
NIH Device Record Key | 6472ba98-1ac0-4199-b32b-ed31d8bf2c69 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | hemochroma PLUS Analyzer |
Version Model Number | 100-101 |
Catalog Number | 100-101 |
Company DUNS | 119214195 |
Company Name | IMMUNOSTICS COMPANY, 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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com | |
Phone | +1(732)918-0770 |
technical@immunostics.com |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10722355003013 [Primary] |
GKR | SYSTEM, HEMOGLOBIN, AUTOMATED |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-07-06 |
Device Publish Date | 2018-12-20 |
10722355001293 - Detector hCG | 2023-07-06 For the qualitative detection of hCG in urine |
10722355001309 - Detector hCG | 2023-07-06 For the qualitative detection of hCG in urine |
10722355001316 - Detector hCG | 2023-07-06 For the qualitative detection of hCG in urine |
10722355001330 - Detector hCG Stick | 2023-07-06 For the qualitative detection of hCG in urine |
10722355001347 - Detector hCG Stick | 2023-07-06 For the qualitative detection of hCG in urine |
10722355001354 - Detector hCG Stick | 2023-07-06 For the qualitative detection of hCG in urine |
10722355001361 - Detector hCG Combi | 2023-07-06 For the qualitative detection of hCG in serum or urine |
10722355001378 - Detector hCG Combi | 2023-07-06 For the qualitative detection of hCG in serum or urine |