| Primary Device ID | 10634853000848 |
| NIH Device Record Key | 2f15ff16-acc2-447f-ad86-3d39194f355b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | General Reagents |
| Version Model Number | 60015 |
| Catalog Number | 60015 |
| Company DUNS | 060467826 |
| Company Name | MICROBIOLOGICS INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10634853000848 [Primary] |
| JTO | Discs, strips and reagents, microorganism differentiation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-04 |
| Device Publish Date | 2022-09-26 |
| 70845357044388 - QC Sets and Panels: Helix Elite™ | 2024-03-26 QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel Sample Kit |
| 10634853000138 - Fungal Serology | 2022-10-04 Immunodiffusion Agar Plates, 1 - 7 Well Pattern |
| 10634853000145 - Fungal Serology | 2022-10-04 Immunodiffusion Agar Plates, 3 - 7 Well Pattern |
| 10634853000152 - Fungal Serology | 2022-10-04 Immunodiffusion Agar Plates, 8 - 7 Well Pattern |
| 10634853000169 - Fungal Serology | 2022-10-04 Normal Rabbit Serum (Negative), 1mL |
| 10634853000176 - Fungal Serology | 2022-10-04 Clarifying Reagent (Sodium Citrate), 20mL |
| 10634853000183 - Fungal Serology | 2022-10-04 Immunodiffusion Agar, 12mL Deeps |
| 10634853000206 - Fungal Serology | 2022-10-04 Candida Antigen, 1mL |