E. coli O150 serum high titer, 1 mL
- Primary DI
- 05713106816004
- Brand
- E. coli O150 serum high titer, 1 mL
- Company
- Ssi Diagnostica A/S
- Model
- 81600
- Catalog number
- 81600
- Device description
- Rabbit antiserum, High titer
- Published
- 2021-08-11
- 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
Product Codes
| Code | Name |
|---|
| GNA | ANTISERA, ALL TYPES, ESCHERICHIA COLI |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GNA | Antisera, All Types, Escherichia Coli | Microbiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05713106816004 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05713106816004 | 05713106816004 | 5713106816004 |
GMDN Terms
| Term | Definition |
|---|
| Escherichia coli antigen IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) 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 | |
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
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 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 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 05032384034420 | DRYSPOT E. COLI O157 | OXOID LIMITED | GNA | 2022-12-04 |
| 05713106544013 | E. coli H4 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544020 | E. coli H5 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544044 | E. coli H6 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544068 | E. coli H7 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544075 | E. coli H8 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544099 | E. coli H9 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544105 | E. coli H10 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544129 | E. coli H11 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544143 | E. coli H12 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544167 | E. coli H14 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544174 | E. coli H15 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544198 | E. coli H16 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544211 | E. coli H17 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544228 | E. coli H18 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544242 | E. coli H19 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544259 | E. coli H20 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544266 | E. coli H21 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544273 | E. coli H23 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544297 | E. coli H24 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544303 | E. coli H25 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544310 | E. coli H26 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544334 | E. coli H27 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544341 | E. coli H28 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544358 | E. coli H29 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544389 | E. coli H30 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544402 | E. coli H31 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544419 | E. coli H32 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544426 | E. coli H33 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
| 05713106544440 | E. coli H34 serum, 5 mL | Ssi Diagnostica A/S | GNA | 2021-08-11 |
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