Primary Device ID | 00810042683716 |
NIH Device Record Key | ab5d8365-e529-4593-822f-8f45d022559b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Salivabuse |
Version Model Number | 18100184 |
Catalog Number | 18100184 |
Company DUNS | 028007698 |
Company Name | BIOCHEMICAL DIAGNOSTICS 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 | 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 | 00810042683716 [Primary] |
DIF | Drug Mixture Control Materials |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-25 |
Device Publish Date | 2023-07-17 |
00810042681163 | Alco-screen Oral Fluid kitbox,4mL |
00810042681149 | CP-OF Panel, 3X, 20mL |
00810042681132 | CP-OF Panel, +50%, 20mL |
00810042681125 | CP-OF Panel, -50%, 20mL |
00810042681118 | Custom Oral Fluid, AU/NZ, Cutoff +50%, 5mL |
00810042681101 | Custom Oral Fluid, Negative, 5mL |
00810042681453 | ORAL FLUID NEGATIVE, 20mL |
00810042681446 | ORAL FLUID NEGATIVE, 5mL |
00810042680005 | Custom Oral Fluid, Negative, 500mL |
00810042681286 | Salivabuse Custom Liquid Control Oral Fluid 20mL |
00810042681279 | Salivabuse Custom Liquid Control Oral Fluid 5mL |
00810042682658 | ORAL-SKREEN, 3X Cutoff, 6x20mL |
00810042682641 | ORAL-SKREEN NEGATIVE, 6x20mL |
00810042682634 | ORAL-SKREEN , Neg/3X POSITIVE KITBOX, 2x20mL |
00810042682627 | Oral Fluid, 3X Cutoff, 20mL |
00810042682610 | Oral Fluid, 2X Cutoff, 20mL |
00810042682603 | Oral Fluid, Cutoff +50%, 20mL |
00810042682597 | Oral Fluid, Cutoff -50%, 20mL |
00810042682580 | NEGATIVE, 20mL |
00810042682573 | NEGATIVE, 500mL |
00810042682887 | Salivabuse Custom Liquid Control Oral Fluid 25mL |
00810042682979 | AUNZS19 Cutoff +50%, 20mL |
00810042682955 | AUNZS19 Cutoff -50%, 20mL |
00810042682467 | AUNZS19 Cutoff +50%, 5mL |
00810042681880 | AUNZS19 Cutoff -50%, 5mL |
00810042683563 | Oral-Skreen, M2 NEGATIVE with Stabilizer, 500mL |
00810042683709 | OF 5 Panel, 3X Cutoff, 25mL |
00810042683693 | OF 6-MAM, 3X Cutoff, 25mL |
00810042683686 | OF Negative M2, 25mL |
00810042683679 | OF 6-MAM, Cutoff +50%, 25mL |
00810042683662 | OF 6-MAM, Cutoff -50%, 25mL |
00810042683655 | OF 5 Panel, Cutoff +50%, 25mL |
00810042683648 | OF 5 Panel, Cutoff -50%, 25mL |
00810042683716 | Negative, pH 6.5 |
00810042683808 | Negative, 25mL |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SALIVABUSE 85648135 4377560 Live/Registered |
Biochemical Diagnostics, Inc. 2012-06-11 |