Identity
- Trade Name
- Northeast Laboratory Services FDA UDI
- Generic Name
- Differential/selective agar culture medium IVD FDA UDI
- Device Name
- Colorex Strep ACG FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Colorex Strep ACG FDA UDI
Identifiers
- Catalog Number
- CHRP0026 FDA UDI
- Primary DI / UDI-DI
- 00810144911359 FDA UDI
- FDA Product Code
- JSI FDA UDI
- GMDN Term
- Differential/selective agar culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2360 FDA UDI
- Commercial Distribution
- Not 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
Northeast Laboratory Services by Northeast Laboratory Services, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Northeast Laboratory Services, Inc.
Sources (1)
- FDA UDI 90d37638-fbeb-470b-bb29-3116d96d176f 35 fields · synced Jun 6, 2026