Primary Device ID | 00850041798028 |
NIH Device Record Key | a52e1f22-b083-4a1a-adc5-6efa7943a8ae |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | N/A |
Version Model Number | K982375 |
Company DUNS | 783601115 |
Company Name | Key Scientific Products Incorporated |
Device Count | 1 |
DM Exempt | true |
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 | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store between 2 and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850041798028 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-18 |
Device Publish Date | 2023-09-08 |
00850041798004 | For qualitative and/or Semi-Qualitative detection of pyrrolidonyl arylamidase (PYR) activity wit |
00850041798035 | For qualitative and/or Semi-Qualitative detection of pyrrolidonyl arylamidase (PYR) activity wit |
00850041798028 | PEP REAGENT |
00850041798011 | he IDENTICULT-AE test is intended for use in the rapid identification of group A streptococci an |
00850041798042 | Pep ReagentT |
00850041798059 | White beads |