| Primary Device ID | 10634853000220 |
| NIH Device Record Key | 5c98f1cc-0fe3-47eb-a61b-60a80f69cb36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fungal Serology |
| Version Model Number | 200190 |
| Catalog Number | 200190 |
| 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and -20 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10634853000220 [Primary] |
| JWT | ANTIGEN, CF, ASPERGILLUS SPP. |
| 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 |
| 10634853000121 | Histoplasma capsulatum Antiserum, 1mL ID/EXO |
| 10634853000114 | Histoplasma capsulatum Antiserum (H&M), 2mL |
| 10634853000107 | Histoplasma capsulatum Antigen (H&M), 2mL ID/EXO |
| 10634853000091 | Histoplasma capsulatum Antigen (H&M), 1mL |
| 10634853000084 | Coccidioides immitis Antiserum (HS), ID/EXO |
| 10634853000077 | Coccidioides immitis Antiserum (F), 2mL |
| 10634853000060 | Coccidioides immitis Antigens (HS), 2mL ID/EXO |
| 10634853000053 | Coccidioides immitis Antigen (F), 1mL |
| 10634853000046 | Blastomyces dermatitidis Antiserum, 2mL |
| 10634853000039 | Blastomyces dermatitidis Antiserum, 1mL ID/EXO |
| 10634853000022 | Blastomyces dermatitidis Antigen (A), 2mL ID/EXO |
| 10634853000015 | Blastomyces dermatitidis Antigen (A), 1mL |
| 10634853000435 | Aspergillus Pooled Antiserum, 2mL |
| 10634853000428 | Aspergillus Pooled Antigen, 1mL |
| 10634853000411 | Aspergillus nidulans Antiserum, 2mL |
| 10634853000404 | Aspergillus nidulans Antigen, 1mL |
| 10634853000398 | Aspergillus terreus Antiserum, 2mL |
| 10634853000343 | Asp. Immunodiffusion Agar, 12mL Deeps |
| 10634853000312 | Asp. Immunodiffusion Agar Plates, 8 - 7 Well Pattern |
| 10634853000305 | Asp. Immunodiffusion Agar Plates, 3 - 7 Well Pattern |
| 10634853000299 | Asp. Immunodiffusion Agar Plates, 1 - 7 Well Pattern |
| 10634853000275 | Aspergillus niger Antiserum, 2mL |
| 10634853000268 | Aspergillus fumigatus Antiserum, 2mL |
| 10634853000251 | Aspergillus flavus Antiserum, 2mL |
| 10634853000244 | Aspergillus niger Antigen, 1mL |
| 10634853000237 | Aspergillus fumigatus Antigen, 1mL |
| 10634853000220 | Aspergillus flavus Antigen, 1mL |
| 10634853000213 | Candida Antiserum, 2mL |
| 10634853000206 | Candida Antigen, 1mL |
| 10634853000183 | Immunodiffusion Agar, 12mL Deeps |
| 10634853000176 | Clarifying Reagent (Sodium Citrate), 20mL |
| 10634853000169 | Normal Rabbit Serum (Negative), 1mL |
| 10634853000152 | Immunodiffusion Agar Plates, 8 - 7 Well Pattern |
| 10634853000145 | Immunodiffusion Agar Plates, 3 - 7 Well Pattern |
| 10634853000138 | Immunodiffusion Agar Plates, 1 - 7 Well Pattern |