Fungal Serology
- Primary DI
- 10634853000428
- Brand
- Fungal Serology
- Company
- MICROBIOLOGICS INC.
- Model
- 200345
- Catalog number
- 200345
- Device description
- Aspergillus Pooled Antigen, 1mL
- Published
- 2022-09-26
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Single use
- true
Contact Domains#
microbiologics.comProduct Codes#
| Code | Name |
|---|---|
| JWT | ANTIGEN, CF, ASPERGILLUS SPP. |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| JWT | Antigen, Cf, Aspergillus Spp. | Microbiology | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10634853000428 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10634853000428 | 10634853000428 |
GMDN Terms#
| Term | Definition |
|---|---|
| Multiple Aspergillus species antigen IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of galactomannan antigens from multiple species of the fungus Aspergillus, which may include Aspergillus niger, Aspergillus flavus, Aspergillus terreus and/or Aspergillus fumigatus, in a clinical specimen. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | -20 Degrees Celsius | -20 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(320)253-7400 | techsupport@microbiologics.com |
Regulatory Flags#
- DUNS number
- 060467826
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
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|---|---|---|---|---|
| 70845357041202 | QC Sets and Panels: Helix Elite™ | 8190 | 8190 | 2020-04-30 |
| 10845357044409 | Helix Elite™ Molecular Standards: Inactivated Standard | HE0082HF | HE0082HF | 2026-04-15 |
| 70845357044340 | QC Sets and Panels: Helix Elite™ | 8248 | 2025-09-08 | |
| 70845357044395 | QC Sets and Panels: Helix Elite™ | 8267 | 2025-09-08 | |
| 70845357044432 | QC Sets and Panels: Helix Elite™ | 8269 | 8269 | 2026-02-10 |
| 70845357044593 | QC Sets and Panels: KWIK-STIK™ 2 Pack | 5260P | 5260P | 2026-01-27 |
| 10845357044324 | Helix Elite™ Molecular Standards: Inactivated Standard | HE0081NS | HE0081NS | 2024-09-04 |
| 10845357020175 | KWIK-STIK™ | 0828U | 0828U | 2020-04-30 |
| 10845357029383 | KWIK-STIK™ | 01018U | 01018U | 2020-04-30 |
| 10845357020199 | LYFO DISK™ | 0828L | 0828L | 2020-04-30 |
| 10845357029406 | LYFO DISK™ | 01018L | 01018L | 2020-04-30 |
| 80845357044422 | Helix Elite Molecular Standards | GS-0001 | 2025-08-14 | |
| 10845357043846 | Helix Elite™ Molecular Standards: Inactivated Standard | HE0071N | HE0071N | 2022-02-16 |
| 10845357043853 | Helix Elite™ Molecular Standards: Inactivated Standard | HE0072NS | HE0072NS | 2022-02-16 |
| 80845357044415 | QC Sets and Panels: Helix Elite™ | CL00016 | CL00016 | 2025-05-27 |
| 10845357043952 | Helix Elite™ Molecular Standards: Inactivated Standard | HE0074NS | HE0074NS | 2022-02-16 |
| 70845357041127 | QC Sets and Panels: Helix Elite™ | 8214 | 8214 | 2020-04-30 |
| 10634853001364 | Tri-Valent™ Swab | CV-01 | CV-01 | 2022-09-26 |
| 10634853001388 | Tri-Valent™ Swab | TVS-01 | TVS-01 | 2022-09-26 |
| 10634853001395 | Tri-Valent™ Swab | TVS-02 | TVS-02 | 2022-09-26 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04048474061291 | Aspergillus fumigatus IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | JWT | 2023-09-01 |
| 00840239061294 | Aspergillus fumigatus IgG ELISA | DRG International Inc | JWT | 2023-08-26 |
| 10634853000220 | Fungal Serology | MICROBIOLOGICS INC. | JWT | 2022-09-26 |
| 10634853000237 | Fungal Serology | MICROBIOLOGICS INC. | JWT | 2022-09-26 |
| 10634853000244 | Fungal Serology | MICROBIOLOGICS INC. | JWT | 2022-09-26 |
| 10634853000404 | Fungal Serology | MICROBIOLOGICS INC. | JWT | 2022-09-26 |
| 07640158216101 | Aspergillus fumigatus IgG ELISA | Bordier affinity products S.A. | JWT | 2022-09-21 |
| 00404847425017 | Aspergillus fumigatus IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | JWT | 2021-06-07 |
| 00404847461299 | Aspergillus fumigatus IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | JWT | 2021-06-07 |
| 00816387020001 | IMMY | Immuno-Mycologics, Inc. | JWT | 2016-09-24 |
| 00816387020025 | IMMY | Immuno-Mycologics, Inc. | JWT | 2016-09-24 |
| 00816387020049 | IMMY | Immuno-Mycologics, Inc. | JWT | 2016-09-24 |
| 00816387020056 | IMMY | Immuno-Mycologics, Inc. | JWT | 2016-09-24 |
| 00816387020063 | IMMY | Immuno-Mycologics, Inc. | JWT | 2016-09-24 |
| 00816387020087 | IMMY | Immuno-Mycologics, Inc. | JWT | 2016-09-24 |
| 00816387020100 | IMMY | Immuno-Mycologics, Inc. | JWT | 2016-09-24 |