Identity
- Trade Name
- Retic-Chex II FDA UDI
- Generic Name
- Reticulocyte count IVD, control FDA UDI
- Device Name
- A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 4 vials of level 2. FDA UDI
- Model / Reference
- 285204 FDA UDI
- Description
- A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 4 vials of level 2. FDA UDI
Identifiers
- Catalog Number
- 285204 FDA UDI
- Primary DI / UDI-DI
- 20844509000383 FDA UDI
- FDA Product Code
- JPK FDA UDI
- GMDN Term
- Reticulocyte count IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1.0 Milliliter FDA UDI
Category: Reticulocyte count IVD, control
Retic-Chex II by Streck — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reticulocyte count IVD, control.
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- Liquichek — Bio-Rad Laboratories · Class II
- Liquichek — Bio-Rad Laboratories · Class II
- Liquichek — Bio-Rad Laboratories · Class II
- Liquichek — Bio-Rad Laboratories · Class II
- CDS-LTX CONTROL — CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Streck
Sources (1)
- FDA UDI 77cdf3bb-1ed2-4c33-98f6-c3c11b798a93 37 fields · synced May 30, 2026