Primary Device ID | 00816870022284 |
NIH Device Record Key | 058d494f-21fc-4033-994a-25850a43b666 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Monobind AccuLite Free PSA CLIA Kit - 192 Wells |
Version Model Number | 2375-300 |
Catalog Number | 2375-300B |
Company DUNS | 083155515 |
Company Name | MONOBIND, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
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 | false |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com | |
Phone | +1(949)951-2665 |
info@monobind.com |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Width | 7.75 Inch |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00816870022284 [Primary] |
LTJ | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-02-06 |
Device Publish Date | 2019-02-11 |
00816870020594 - Monobind AccuBind Free PSA ELISA Kit - 96 Wells | 2020-02-06 |
00816870020600 - Monobind AccuBind Free PSA ELISA Kit - 192 Wells | 2020-02-06 |
00816870020617 - Monobind AccuBind PSA ELISA Kit - 96 Wells | 2020-02-06 |
00816870020624 - Monobind AccuBind PSA ELISA Kit - 192 Wells | 2020-02-06 |
00816870020631 - Monobind AccuBind PSA Extra Sensitive ELISA Kit - 96 Wells | 2020-02-06 |
00816870020648 - Monobind AccuBind PSA Extra Sensitive ELISA Kit - 192 Wells | 2020-02-06 |
00816870022277 - Monobind AccuLite Free PSA CLIA Kit - 96 Wells | 2020-02-06 |
00816870022284 - Monobind AccuLite Free PSA CLIA Kit - 192 Wells | 2020-02-06 |
00816870022284 - Monobind AccuLite Free PSA CLIA Kit - 192 Wells | 2020-02-06 |