Tanner Scientific® TNR HCGCOMBO
GUDID 00850011007174
Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,Pregnancy Urine/Serum Combo 50BX
MERCEDES MEDICAL, LLC
Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin (HCG) IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent Total human chorionic gonadotropin IVD, reagent| Primary Device ID | 00850011007174 |
| NIH Device Record Key | 52f62a54-7295-49ac-ab54-b50481a11af2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tanner Scientific® |
| Version Model Number | TNR HCGCOMBO |
| Catalog Number | TNR HCGCOMBO |
| 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
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850011007174 [Primary] |
| GS1 | 10850011007171 [Package] Package: Inner Pack [50 Units] In Commercial Distribution |
| GS1 | 20850011007178 [Package] Contains: 10850011007171 Package: Case [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K112101
FDA Product Code
| JHI | Visual, Pregnancy Hcg, Prescription Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-22 |
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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