Primary Device ID | 00857031002646 |
NIH Device Record Key | 2d44be71-45af-4076-af83-d30243b1c0f1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | C. DIFFICILE TOX A/B II |
Version Model Number | T5015XB |
Company DUNS | 614218634 |
Company Name | TECHLAB, 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 | true |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00857031002646 [Primary] |
LLH | Reagents, Clostridium Difficile Toxin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-05-17 |
Device Publish Date | 2021-05-07 |
00857031002424 | The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B |
00857031002103 | The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B |
00857031002219 | The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B |
00857031002431 | The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B |
00857031002646 | The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B |