Identity
- Trade Name
- Simmler, Inc. FDA UDI
- Generic Name
- Haemoglobin F (HbF) IVD, reagent FDA UDI
- Device Name
- Fetal Cell Stain Kit 100 Test FDA UDI
- Model / Reference
- S0412-100 FDA UDI
- Description
- Fetal Cell Stain Kit 100 Test FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851318008017 FDA UDI
- FDA Product Code
- GHQ FDA UDI
- GMDN Term
- Haemoglobin F (HbF) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7455 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
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: Haemoglobin F (HbF) IVD, reagent
Simmler, Inc. by Simmler, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemoglobin F (HbF) IVD, reagent.
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- D-10 Dual — Bio-Rad Laboratories · Class II
- Anti-HbF Dy-410 — IQ Products B.V. · Class I
- D-10 — Bio-Rad Laboratories · Class II
- D-10 — Bio-Rad Laboratories · Class II
- D-10 Dual — Bio-Rad Laboratories · Class II
- VARIANT II B-thalassemia — Bio-Rad Laboratories · 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
- Simmler, Inc.
Sources (1)
- FDA UDI 75b9c519-3187-4071-a200-bbabd067cf95 34 fields · synced Jun 6, 2026