NA
- Primary DI
- 00848838076817
- Brand
- NA
- Company
- REMEL, INC.
- Model
- DR0780M
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| KTN | System, Test, Infectious Mononucleosis |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KTN | System, Test, Infectious Mononucleosis | Immunology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00848838076817 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00848838076817 | 00848838076817 | 848838076817 | 0848838076817 |
GMDN Terms
| Term | Definition |
|---|
| Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of heterophile antibodies produced in response to Epstein-Barr virus (EBV) in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever. |
Regulatory Flags
- DUNS number
- 065769564
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00848838059865 | ^BM^ PK/50 OXIDASE TEST | R9055635 | | 2026-01-16 |
| 00842558116402 | BactiSwab Dry PK/100 | R723135 | | 2025-06-19 |
| 00848838066665 | Amies Clear Gel,Single Swab PK/500 | R723000 | | 2025-06-18 |
| 00848838066672 | Amies Clear Gel,Single Swab PK/50 | R723005 | | 2025-06-18 |
| 00848838066689 | Amies Clear Gel,Dual Swab PK/500 | R723010 | | 2025-06-18 |
| 00848838066696 | Amies Clear Gel,Dual Swab PK/50 | R723015 | | 2025-06-18 |
| 00848838066702 | Amies Clear Gel,Wire Shaft Swab PK/100 | R723020 | | 2025-06-18 |
| 00848838066719 | Amies Clear Gel,Wire Shaft PK/50 | R723025 | | 2025-06-18 |
| 00848838066757 | Amies Charcoal Gel,Single Swab PK/50 | R723045 | | 2025-06-18 |
| 00848838066856 | Liquid Amies,Dual Swab PK/50 | R723095 | | 2025-06-18 |
| 00848838066887 | Liquid Stuarts,Single Swab PK/500 | R723110 | | 2025-06-18 |
| 00848838066894 | Liquid Stuarts,Single Swab PK/50 | R723115 | | 2025-06-18 |
| 00848838066900 | Liquid Stuarts,Dual Swab PK/500 | R723120 | | 2025-06-18 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 10885380183638 | CARDINAL HEALTH | Cardinal Health 200, LLC | KTN | 2022-08-29 |
| M220P0800163 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | KTN | 2017-02-13 |
| 00742860100048 | MONO, MERIDIAN IMMUNO 25 Test Kit | SEKISUI DIAGNOSTICS, LLC | KTN | 2017-01-10 |
| 20612479202775 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | KTN | 2016-12-09 |
| 00722066000311 | Rapid Response | BTNX Inc | KTN | 2016-10-25 |
| 30888277191895 | MEDLINE | MEDLINE INDUSTRIES, INC. | KTN | 2016-10-14 |
| 10888277191891 | Medline | MEDLINE INDUSTRIES, INC. | KTN | 2016-10-14 |
| 20304040024137 | Henry Schein | HENRY SCHEIN, INC. | KTN | 2016-09-24 |
| 10815845020000 | Clearview® | ALERE SAN DIEGO, INC. | KTN | 2016-09-24 |
| 10815845020017 | Acceava® | ALERE SAN DIEGO, INC. | KTN | 2016-09-24 |
| 10815845020062 | Signify® | ALERE SAN DIEGO, INC. | KTN | 2016-09-24 |
| 10859035006238 | Acceava® Mono Cassette | ALERE NORTH AMERICA, LLC | KTN | 2016-09-24 |
| 00848838031588 | NA | REMEL, INC. | KTN | 2016-09-24 |
| 00848838031601 | NA | REMEL, INC. | KTN | 2016-09-24 |
| 00848838065262 | NA | REMEL, INC. | KTN | 2016-09-24 |
| 00848838065279 | NA | REMEL, INC. | KTN | 2016-09-24 |
| 00848838065385 | NA | REMEL, INC. | KTN | 2016-09-24 |
| 20613647000285 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | KTN | 2016-09-24 |
| 00613647001196 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | KTN | 2016-09-24 |
| 00613647001202 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | KTN | 2016-09-24 |
| 00613647001301 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | KTN | 2016-09-24 |
| 00613647001318 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | KTN | 2016-09-24 |
| 00613647001325 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | KTN | 2016-09-24 |
| 00304040001387 | Henry Schein OneStep | HENRY SCHEIN, INC. | KTN | 2016-09-24 |
| 08426950344773 | Color Mono 50 TESTS | BIOKIT, S.A. | KTN | 2016-09-23 |
| 10743816000921 | BioSign® Mono card | PRINCETON BIOMEDITECH CORPORATION | KTN | 2016-09-23 |
| 10743816000938 | BioSign® Mono card | PRINCETON BIOMEDITECH CORPORATION | KTN | 2016-09-23 |
| 10743816000945 | Status Mono Moderate Complex card | PRINCETON BIOMEDITECH CORPORATION | KTN | 2016-09-23 |
| 10743816000952 | Status Mono Waived card | PRINCETON BIOMEDITECH CORPORATION | KTN | 2016-09-23 |
| 10743816000969 | Status Mono Waived card | PRINCETON BIOMEDITECH CORPORATION | KTN | 2016-09-23 |
remel.com