21 CFR 864.6550 — Guaiac Reagent
Hematology (HE) · Part 864 Subpart G—Manual Hematology Devices · § 864.6550
Identification
An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)
Classification Rationale
Class II (special controls). A control intended for use with an occult blood test 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 |
|---|---|---|---|---|
| GGG | Guaiac Reagent | 2 | 1 | 3rd Party |
| JIO | Blood, Occult, Colorimetric, In Urine | 2 | 11 | 3rd Party |
| JIP | Blood, Occult, Enzymatic Method, In Urine | 2 | 0 | 3rd Party |
| KHE | Reagent, Occult Blood | 2 | 97 | 3rd Party |
| NGK | Test, Occult Blood, Over The Counter | 2 | 0 | 3rd Party |
| OOX | Automated Occult Blood Analyzer | 2 | 6 | 3rd Party |
| OSL | Control, Fecal Occult Blood | 2 | 1 |
Special Controls
GGG — Guaiac Reagent
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
JIO — Blood, Occult, Colorimetric, In Urine
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
JIP — Blood, Occult, Enzymatic Method, In Urine
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
KHE — Reagent, Occult Blood
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
NGK — Test, Occult Blood, Over The Counter
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
OOX — Automated Occult Blood Analyzer
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
OSL — Control, Fecal Occult Blood
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
