21 CFR 864.7415 — Hemoglobin S
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7415
Identification
An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.
Classification Rationale
Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GIQ | Hemoglobin S | 2 | 3 | 3rd Party |
| GKA | Abnormal Hemoglobin Quantitation | 2 | 23 | 3rd Party |
| JCM | Control, Hemoglobin, Abnormal | 2 | 12 | |
| JPB | Hemoglobin M | 2 | 0 | 3rd Party |
| MLL | Hemoglobin C (Abnormal Hemoglobin Variant) | 2 | 1 | 3rd Party |
Special Controls
GIQ — Hemoglobin S
*Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GKA — Abnormal Hemoglobin Quantitation
*Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
JCM — Control, Hemoglobin, Abnormal
*Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
JPB — Hemoglobin M
*Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
MLL — Hemoglobin C (Abnormal Hemoglobin Variant)
*Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
