NA
- Primary DI
- 00848838003264
- Brand
- NA
- Company
- REMEL, INC.
- Model
- R01880
- 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
Related Records
Contact Domains
remel.comProduct Codes
| Code | Name |
|---|---|
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | Microbiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00848838003264 | Primary | GS1 | 0 | |
| 00848838099533 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00848838003264 | 00848838003264 | 848838003264 | 0848838003264 |
| 00848838099533 | 00848838099533 | 848838099533 | 0848838099533 |
GMDN Terms
| Term | Definition |
|---|---|
| Thayer-Martin Neisseria species agar culture medium IVD | A selective and/or differential agar culture medium that uses the Thayer-Martin formulation, or modified formulation, and is intended to be used for the growth and isolation of Neisseria gonorrhoea and other Neisseria species from a clinical specimen. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| 8002556730 | ITechnicalSupport@remel.com |
Regulatory Flags
- DUNS number
- 065769564
- Device count
- 10
- DM exempt
- false
- Premarket exempt
- true
- 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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| 00848838091742 | VersaTREK™ | VersaTREK™ Myco Streptomycin, 7120-30 | 2025-01-16 | |
| 00848838003158 | Strep Selective II Agar | R01859 | 2026-01-16 | |
| 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 |
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| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00816576020072 | NA | HARDY DIAGNOSTICS | JTY | 2020-03-31 |
| 30382902212677 | BD BBL™ Chocolate II Agar | BECTON, DICKINSON AND COMPANY | JTY | 2016-12-21 |
| 30382902215685 | BD BBL™ Modified Thayer-Martin (MTM II) Agar | BECTON, DICKINSON AND COMPANY | JTY | 2016-12-21 |
| 30382902215586 | BD BBL™ Martin-Lewis Agar | BECTON, DICKINSON AND COMPANY | JTY | 2016-12-21 |
| 30382902962718 | BD BBL™ Chocolate II Agar with Bacitracin | BECTON, DICKINSON AND COMPANY | JTY | 2016-12-21 |
| 30382902211694 | BD BBL™ Chocolate II Agar | BECTON, DICKINSON AND COMPANY | JTY | 2016-12-21 |
| 30382902213025 | BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II Agar | BECTON, DICKINSON AND COMPANY | JTY | 2016-12-21 |
| 30382902213032 | BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II Agar | BECTON, DICKINSON AND COMPANY | JTY | 2016-12-21 |
| 30382902215579 | BD BBL™ Martin-Lewis Agar | BECTON, DICKINSON AND COMPANY | JTY | 2016-12-21 |
| 30382902215678 | BD BBL™ Modified Thayer-Martin (MTM II) Agar | BECTON, DICKINSON AND COMPANY | JTY | 2016-12-21 |
| 30382902216231 | BD BBL™ Chocolate II Agar/Modified Thayer-Martin Agar | BECTON, DICKINSON AND COMPANY | JTY | 2016-12-21 |
| 30382902977156 | BD BBL™ GC-Lect™ Agar | BECTON, DICKINSON AND COMPANY | JTY | 2016-12-21 |
| 30382902979280 | BD BBL™ GC-Lect™ Agar | BECTON, DICKINSON AND COMPANY | JTY | 2016-12-21 |
| 00848838001796 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838003271 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838003288 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838003295 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838003301 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838003318 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838003738 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838004469 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838014116 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838014123 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838014321 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838014338 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838014345 | NA | REMEL, INC. | JTY | 2016-09-24 |
| 00848838014369 | NA | REMEL, INC. | JTY | 2016-09-24 |
| B08810804 | InTray™ GC | BIO-MED DIAGNOSTICS, INC. | JTY | 2016-09-21 |
| 00816576020089 | NA | HARDY DIAGNOSTICS | JTY | 2016-09-02 |
| 00816576020195 | NA | HARDY DIAGNOSTICS | JTY | 2016-09-02 |