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Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1255
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1255 2,3-Diphosphoglyceric acid test system

§ 862.1255 2,3-Diphosphoglyceric acid test system.

(a) Identification. A 2,3-diphosphoglyceric acid test system is a device intended to measure 2,3-diphosphoglyceric acid (2,3-DPG) in erythrocytes (red blood cells). Measurements of 2,3-diphosphoglyceric acid are used in the diagnosis and treatment of blood disorders that affect the delivery of oxygen by erythrocytes to tissues and in monitoring the quality of stored blood.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001]

Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1255
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1255 2,3-Diphosphoglyceric acid test system

§ 862.1255 2,3-Diphosphoglyceric acid test system.

(a) Identification. A 2,3-diphosphoglyceric acid test system is a device intended to measure 2,3-diphosphoglyceric acid (2,3-DPG) in erythrocytes (red blood cells). Measurements of 2,3-diphosphoglyceric acid are used in the diagnosis and treatment of blood disorders that affect the delivery of oxygen by erythrocytes to tissues and in monitoring the quality of stored blood.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001]