Identity
- Trade Name
- StrepPRO™ FDA UDI
- Generic Name
- Beta-haemolytic Streptococcus serological grouping IVD, reagent FDA UDI
- Device Name
- StrepPRO™ Positive Control, for the rapid latex agglutination test, 60 tests Positive Control for the rapid latex agglutination test for the identification of streptococcal groups. FDA UDI
- Model / Reference
- PL040HD FDA UDI
- Description
- StrepPRO™ Positive Control, for the rapid latex agglutination test, 60 tests Positive Control for the rapid latex agglutination test for the identification of streptococcal groups. FDA UDI
Identifiers
- Catalog Number
- PL040HD FDA UDI
- Primary DI / UDI-DI
- 00819398027946 FDA UDI
- FDA Product Code
- GTZ FDA UDI
- GMDN Term
- Beta-haemolytic Streptococcus serological grouping IVD, reagent 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
Yes
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
No
FDA UDI
Category: Beta-haemolytic Streptococcus serological grouping IVD, reagent
StrepPRO™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-haemolytic Streptococcus serological grouping IVD, reagent.
- Latex Grouping Reagent G — OXOID LIMITED · Class I
- Latex Grouping Reagent F — OXOID LIMITED · Class I
- Latex Grouping Reagent D — OXOID LIMITED · Class I
- Latex Grouping Reagent C — OXOID LIMITED · Class I
- Latex Grouping Reagent B — OXOID LIMITED · Class I
- StrepPRO™ — HARDY DIAGNOSTICS · Class I
- StrepPRO™ — HARDY DIAGNOSTICS · Class I
- StrepPRO™ — HARDY DIAGNOSTICS · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI fb71f710-8c55-4d1e-b29d-00a03702dce7 36 fields · synced May 30, 2026