Tanner Scientific® TNR IFOB36
GUDID 00850011007167
Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 36/BX
MERCEDES MEDICAL, LLC
Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00850011007167 |
| NIH Device Record Key | 09b66a5e-511b-4098-a0ff-9251f4f23ee4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tanner Scientific® |
| Version Model Number | TNR IFOB36 |
| Catalog Number | TNR IFOB36 |
| Company DUNS | 834472680 |
| Company Name | MERCEDES MEDICAL, LLC |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850011007167 [Primary] |
| GS1 | 10850011007164 [Package] Package: Inner Pack [36 Units] In Commercial Distribution |
| GS1 | 20850011007161 [Package] Contains: 10850011007164 Package: Case [30 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110309
FDA Product Code
| KHE | Reagent, Occult Blood |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-15 |
On-Brand Devices [Tanner Scientific®]
| 00850011007174 | Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,Pregnancy Urine/S |
| 00850011007167 | Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 36/BX |
| 00850011007150 | Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 20/BX |
| 00850011007143 | Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ketone, Specific Gr |
| 20850011007130 | Tanner Scientific CLIA waived 13 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/OXY/PCP/TCA/THC |
| 20850011007123 | Tanner Scientific CLIA waived Drug Cup; 12Panel AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/OXY/PCP/ |
Trademark Results [Tanner Scientific]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TANNER SCIENTIFIC 86239556 4628677 Live/Registered |
MERCEDES MEDICAL, LLC 2014-04-02 |
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