← Back to catalogue
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP FDA UDI
- Generic Name
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 50 tests/kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974849369281 FDA UDI
- FDA Product Code
- NJR FDA UDI
- GMDN Term
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class I — IVDD, FDA UDI…
Similar devices
Also classified as Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT).
- Xpert® — CEPHEID · Class I
- Xpert GBS LB — CEPHEID · Class I
- Xpert GBS LB — CEPHEID · Class I
- Alethia™ Group B Streptococcus — MERIDIAN BIOSCIENCE, INC. · Class I
- GeneXpert® — CEPHEID · Class I
- Group B Strep Assay — Great Basin Scientific, Inc. · Class II
- Simplexa™ GBS Direct — DiaSorin Molecular LLC · Class II
- Revogene GBS LB — MERIDIAN BIOSCIENCE, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Sources (2)
- FDA UDI e8dcca5d-6d1c-420c-8ae8-c3412744648f 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026