Identity
- Trade Name
- Testosterone AccuLite CLIA Test System - 192 Wells FDA UDI
- Generic Name
- Total testosterone IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 3775-300 FDA UDI
Identifiers
- Catalog Number
- 3775-300B FDA UDI
- Primary DI / UDI-DI
- 00816870022949 FDA UDI
- FDA Product Code
- CDZ FDA UDI
- GMDN Term
- Total testosterone IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1680 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Dimensions & Sizes
- Size
- Width — 7.75 Inch FDA UDI
Category: Total testosterone IVD, kit, chemiluminescent immunoassay
Testosterone AccuLite CLIA Test System - 192 Wells by Monobind, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Monobind, Inc.
Sources (1)
- FDA UDI cbbefcb5-cbda-4626-84c6-ad9f3b5aa837 36 fields · synced May 30, 2026