Primary Device ID | 10722355001279 |
NIH Device Record Key | 5ed36c5d-ad86-4490-a3ca-4e9c42eb8255 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Detector Monocol Lex |
Version Model Number | MCLX-50 |
Company DUNS | 119214195 |
Company Name | Immunostics Company, Inc |
Device Count | 50 |
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 | true |
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 |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10722355001279 [Primary] |
GS1 | 80722355001278 [Unit of Use] |
KTN | SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2025-03-31 |
Device Publish Date | 2016-09-20 |
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10722355001286 | A rapid color enhanced latex agglutination slide test for the detection of heterophile antibodie |
10722355001279 | A rapid color enhanced latex agglutination slide test for the detection of heterophile antibodie |