ImmuLex Streptococcus Type IV, 1,5 mL
- Primary DI
- 05713106549865
- Brand
- ImmuLex Streptococcus Type IV, 1,5 mL
- Company
- Ssi Diagnostica A/S
- Model
- 54986
- Catalog number
- 54986
- Device description
- Rabbit antiserum, Ready to use
- Published
- 2021-08-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Contact Domains
ssidiagnostica.comProduct Codes
| Code | Name |
|---|---|
| GTZ | ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | Microbiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05713106549865 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05713106549865 | 05713106549865 | 5713106549865 |
GMDN Terms
| Term | Definition |
|---|---|
| Multiple Streptococcus species antigen IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative detection of antigens from multiple species of Streptococcus bacteria in a clinical specimen and/or culture isolate. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +4548299100 | info@ssidiagnostica.com |
Regulatory Flags
- DUNS number
- 305684449
- Device count
- 1
- 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
Other Devices From This Company
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|---|---|---|---|---|
| 05713106994627 | Dermatophyte and C. albicans Real Time PCR kit | 99462 | 99462 | 2022-11-25 |
| 05713106105573 | ImmuView S. pneumoniae and L. pneumophila urinary antigen test | 10557 | 10557 | 2022-10-25 |
| 05713106544013 | E. coli H4 serum, 5 mL | 54401 | 54401 | 2021-08-11 |
| 05713106544020 | E. coli H5 serum, 5 mL | 54402 | 54402 | 2021-08-11 |
| 05713106544044 | E. coli H6 serum, 5 mL | 54404 | 54404 | 2021-08-11 |
| 05713106544068 | E. coli H7 serum, 5 mL | 54406 | 54406 | 2021-08-11 |
| 05713106544075 | E. coli H8 serum, 5 mL | 54407 | 54407 | 2021-08-11 |
| 05713106544099 | E. coli H9 serum, 5 mL | 54409 | 54409 | 2021-08-11 |
| 05713106544105 | E. coli H10 serum, 5 mL | 54410 | 54410 | 2021-08-11 |
| 05713106544129 | E. coli H11 serum, 5 mL | 54412 | 54412 | 2021-08-11 |
| 05713106544143 | E. coli H12 serum, 5 mL | 54414 | 54414 | 2021-08-11 |
| 05713106544167 | E. coli H14 serum, 5 mL | 54416 | 54416 | 2021-08-11 |
| 05713106544174 | E. coli H15 serum, 5 mL | 54417 | 54417 | 2021-08-11 |
| 05713106544198 | E. coli H16 serum, 5 mL | 54419 | 54419 | 2021-08-11 |
| 05713106544211 | E. coli H17 serum, 5 mL | 54421 | 54421 | 2021-08-11 |
| 05713106544228 | E. coli H18 serum, 5 mL | 54422 | 54422 | 2021-08-11 |
| 05713106544242 | E. coli H19 serum, 5 mL | 54424 | 54424 | 2021-08-11 |
| 05713106544259 | E. coli H20 serum, 5 mL | 54425 | 54425 | 2021-08-11 |
| 05713106544266 | E. coli H21 serum, 5 mL | 54426 | 54426 | 2021-08-11 |
| 05713106544273 | E. coli H23 serum, 5 mL | 54427 | 54427 | 2021-08-11 |
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| 05713106549834 | ImmuLex Streptococcus Type Ib, 1,5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106549841 | ImmuLex Streptococcus Type II, 1,5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106549858 | ImmuLex Streptococcus Type III, 1,5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106549872 | ImmuLex Streptococcus Type V, 1,5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106549889 | ImmuLex Streptococcus Type VI, 1,5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106549896 | ImmuLex Streptococcus Type VII, 1,5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106549902 | ImmuLex Streptococcus Type VIII, 1,5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106697450 | ImmuLex Streptococcus Type IX, 1,5 ml | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106732588 | ImmuLex Streptococcus Group A, 1.5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106732595 | ImmuLex Streptococcus Group B, 1.5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106732601 | ImmuLex Streptococcus Group C, 1.5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106732618 | ImmuLex Streptococcus Group D, 1.5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106732625 | ImmuLex Streptococcus Group F, 1.5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106732632 | ImmuLex Streptococcus Group G, 1.5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
| 05713106732649 | ImmuLex Streptococcus Group L, 1.5 mL | Ssi Diagnostica A/S | GTZ | 2021-08-01 |
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| 05056080501253 | PathoDx Strep B Grouping Latex | REMEL EUROPE LIMITED | GTZ | 2021-07-21 |
| 05056080501260 | PathoDx Strep C Grouping Latex | REMEL EUROPE LIMITED | GTZ | 2021-07-21 |
| 05056080501277 | PathoDx Strep F Grouping Latex | REMEL EUROPE LIMITED | GTZ | 2021-07-21 |
| 05056080501284 | PathoDx Strep G Grouping Latex | REMEL EUROPE LIMITED | GTZ | 2021-07-21 |
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