Anti-Streptolysin O (ASO)
- Primary DI
- 05055273204292
- Brand
- Anti-Streptolysin O (ASO)
- Company
- RANDOX LABORATORIES LIMITED
- Model
- LO2715
- Published
- 2019-06-03
- 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
Product Codes
| Code | Name |
|---|---|
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | Microbiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05055273204292 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05055273204292 | 05055273204292 | 5055273204292 |
GMDN Terms
| Term | Definition |
|---|---|
| Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to streptolysin O enzyme produced by Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using a nephelometry/turbidimetry method. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 227530649
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- 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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|---|---|---|---|---|
| 05055273218985 | ConcizuTrace™ ELISA | CZM10591 | CZM10591 | 2025-05-30 |
| 05055273210101 | Liquid Immunoassay Control – Level 1 (IA CONTROL 1) | LIA5142 | LIA5142 | 2025-03-24 |
| 05055273210118 | LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2) | LIA5143 | LIA5143 | 2025-03-24 |
| 05055273210125 | LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3) | LIA5144 | LIA5144 | 2025-03-24 |
| 05055273219814 | PTH CONTROL LEVEL 1 (PTH CONTROL 1) | PTH10608 | PTH10608 | 2025-03-24 |
| 05055273219821 | PTH CONTROL LEVEL 2 (PTH CONTROL 2) | PTH10609 | PTH10609 | 2025-03-24 |
| 05055273219838 | PTH CONTROL LEVEL 3 (PTH CONTROL 3) | PTH10610 | PTH10610 | 2025-03-24 |
| 05055273219043 | LIQUID CARDIAC CONTROL 1 | CQ10534 | CQ10534 | 2025-03-21 |
| 05055273219050 | LIQUID CARDIAC CONTROL 2 | CQ10535 | CQ10535 | 2025-03-21 |
| 05055273219067 | LIQUID CARDIAC CONTROL 3 | CQ10536 | CQ10536 | 2025-03-21 |
| 05055273219128 | LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1) | CQ10616 | CQ10616 | 2025-03-21 |
| 05055273219135 | LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2) | CQ10617 | CQ10617 | 2025-03-21 |
| 05055273219142 | LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3) | CQ10618 | CQ10618 | 2025-03-21 |
| 05055273219159 | Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) | LAL10565 | LAL10565 | 2025-03-21 |
| 05055273219166 | Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) | LAN10566 | 2025-03-21 | |
| 05055273219173 | Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3) | LAE10567 | LAE10567 | 2025-03-21 |
| 05055273219180 | Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) | LAL10625 | LAL10625 | 2025-03-21 |
| 05055273219197 | Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) | LAN10626 | LAN10626 | 2025-03-21 |
| 05055273219203 | Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3) | LAE10627 | LAE10627 | 2025-03-21 |
| 05055273220018 | PlaySafe™ | SCK10690 | SCK10690 | 2024-10-01 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10673486002447 | Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set | TECO DIAGNOSTICS | GTQ | 2024-04-02 |
| 00630414305097 | Atellica CH Anti-Streptolysin-O_3 (ASO_3) | Siemens Healthcare Diagnostics Inc. | GTQ | 2024-02-02 |
| 06971674867067 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | GTQ | 2023-07-24 |
| 06971674867074 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | GTQ | 2023-07-24 |
| 06971674867081 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | GTQ | 2023-07-24 |
| 06971674867104 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | GTQ | 2023-07-24 |
| 06971674867111 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | GTQ | 2023-07-24 |
| 06971674867128 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | GTQ | 2023-07-24 |
| 06971674867135 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | GTQ | 2023-07-24 |
| 06971674867838 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | GTQ | 2023-07-24 |
| 00894175000619 | InstaTest™ | Diagnostic Automation, Inc. | GTQ | 2021-12-13 |
| 04015630920860 | Tina-quant Antistreptolysin O | Roche Diagnostics GmbH | GTQ | 2021-01-18 |
| 04015630925711 | Tina-quant Antistreptolysin O | Roche Diagnostics GmbH | GTQ | 2021-01-18 |
| 00630414517681 | ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents | Siemens Healthcare Diagnostics Inc. | GTQ | 2020-09-24 |
| 00630414596167 | Atellica CH ASO_2 | Siemens Healthcare Diagnostics Inc. | GTQ | 2020-09-24 |
| 00842768006036 | Dimension Vista®Antistreptolysin O Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | GTQ | 2020-09-24 |
| 00842768006791 | N Latex ASL | Siemens Healthcare Diagnostics Products GmbH | GTQ | 2020-09-24 |
| 00842768006807 | N Latex ASL | Siemens Healthcare Diagnostics Products GmbH | GTQ | 2020-09-24 |
| 10758750002306 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | GTQ | 2020-04-18 |
| 10758750002726 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | GTQ | 2020-04-18 |
| 10758750002733 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | GTQ | 2020-04-18 |
| 07613336133545 | Tina-quant Antistreptolysin O | Roche Diagnostics GmbH | GTQ | 2020-03-05 |
| 00380740156251 | ARCHITECT | ABBOTT LABORATORIES | GTQ | 2020-03-03 |
| 00380740156305 | ARCHITECT | ABBOTT LABORATORIES | GTQ | 2020-03-03 |
| 00380740156381 | ARCHITECT | ABBOTT LABORATORIES | GTQ | 2020-03-03 |
| 00380740156398 | ARCHITECT | ABBOTT LABORATORIES | GTQ | 2020-03-03 |
| 05055273204315 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | RANDOX LABORATORIES LIMITED | GTQ | 2019-06-03 |
| 05055273204322 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | RANDOX LABORATORIES LIMITED | GTQ | 2019-06-03 |
| 05055273209174 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | RANDOX LABORATORIES LIMITED | GTQ | 2019-06-03 |
| 05055273209181 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | RANDOX LABORATORIES LIMITED | GTQ | 2019-06-03 |